Clinical trial NCT01294358
Conditions: Histologically or Cytologically Confirmed Pancreatic Ca Unresectable or Borderline Resectable Pancreatic Ca
Keywords: Pancreatic Cancer Regional Therapy Selective Arterial Infusion Locally Advanced Disease
Sponsor: National Cancer Institute (NCI)
Start date: 2011-01-26; Completion date: 2014-07-23
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Background:

\- Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink some of the tumor, but even with chemotherapy only about 25 percent of patients will live for 1 year following diagnosis. Several preliminary studies have shown that it is safe to give chemotherapy directly into the pancreas in the area of the tumor, and that giving gemcitabine over a longer period increases the amount of drug that is available to the tumor. Researchers are interested in studying whether giving the approved pancreatic cancer chemotherapy drug gemcitabine directly into the pancreas in the area of the cancer and at a slow rate of infusion is a safe and effective treatment.

Objectives:

\- To test the safety and effectiveness of administering gemcitabine directly to a pancreatic tumor at a slow rate of infusion.

Eligibility:

\- Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that is currently too large to be removed surgically but has not yet spread to other organs.

Design:

* Participants will be screened with a full medical history and physical examination, blood and urine tests, and imaging studies.
* Participants will undergo pancreatic angiography and embolization, during which a catheter will be threaded into the blood vessels near the pancreas and a contrast dye will be used to show the blood vessels supplying the tumor. These blood vessels will then be surgically closed off.
* After the embolization, gemcitabine will be given as an infusion into the area around the tumor over 24 hours.
* Participants will return to the clinical center every 2 weeks after the first infusion for additional infusions of gemcitabine, using the same procedures as above. Participants will be monitored with frequent blood tests and imaging studies.
* Two weeks after the fourth treatment (course 1), participants will have more imaging studies, a physical examination, and blood tests. If the tumor is shrinking, participants will have two more courses of treatment (eight more infusions of gemcitabine).
* Participants will have followup visits every 3 months for 2 years following the last treatment and then every 6 months.

Detailed description:
Background:

* Pancreatic cancer is the fourth leading cause of cancer death in the United States.
* Surgery offers the only chance at cure; however, less than 20% of patients are considered resectable at initial presentation.
* A common reason for being classified as unresectable is loco-regional advanced disease.
* Several phase I studies of regional administration of chemotherapy have proven safe.
* The main advantage of pancreatic cancer targeted arterial perfusion of Gemcitabine is achievement of higher local bio-available active drug levels at the tumor bed.
* The Regional Chemotherapy in Locally Advanced Pancreatic Cancer (RECLAP) trial is a phase I trial offering highly selective 24-hour intra-arterial administration of Gemcitabine via a subcutaneous port for patients with unresectable locally-advanced pancreatic cancer.

Objectives:

Primary Objective:

* To evaluate feasibility and toxicity of intra-arterial gemcitabine therapy (dose limiting toxicity (DLT)).
* To establish the maximum tolerated dose (MTD)

Secondary Objectives:

* To evaluate response rate using Response Evaluation Criteria in Solid Tumors (RECIST), positron emission tomography (PET), magnetic resonance imaging (MRI) and computed tomography (CT) perfusion criteria (European Association for the Study of the Liver (EASL))
* To determine progression free and overall survival.
* To evaluate the conversion rate from unresectable or borderline resectable to potentially resectable pancreatic cancer.
* To determine progression-free and overall survival.
* To analyze potential selection criteria to be used in future studies for patients who present with marginally unresectable or unresectable locally-advanced pancreatic cancer that might benefit from this approach.

Eligibility:

* Unresectable locally-advanced pancreatic cancer.
* 18 years old or greater with an Eastern Cooperative Oncology Group (ECOG) 0-2
* Laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to surgery or chemotherapy.
* No extra-pancreatic disease except regional lymph nodes.

Design:

* This is a dose escalation phase-I study.
* Patients considered unresectable due to locally-advanced pancreatic cancer will receive selective arterial perfusion of gemcitabine over 24 hours via a subcutaneous indwelling port.
* Treatment will be given on Days 1 and 14. One cycle = 4 weeks for up to six cycles.
* Three to six patients will be enrolled per dose cohort.
* 18 to 36 patients in 7 cohorts will be accrued plus 6 more patients at the maximum tolerated dose (MTD over 36 months. Patients will be evaluated every 2 cycles (8 weeks). Upon progression patients will be taken off study. If no progressive disease (PD), patients will continue up to 6 cycles.
* Chemotherapy na(SqrRoot) ve patients and patients who received previously chemotherapy including gemcitabine will be allowed, as this mode of administration has better bioavailability, offer potential for better biological effect and less systemic toxicity profiles.

Arms: arm 1: gemcitabine dose escalation
Interventions: intervention 1: Gemcitabine
Intervention descriptions: intervention 1: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.

Protocol documents:
ICF_001.pdf: 
 
 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
   MEDICAL RECORD 
               •  Adult Patient or     •  Parent, for Minor Patient 
 
 
INSTITUTE: 
National Cancer Institute 
 
STUDY NUMBER: 11-C-0099 
PRINCIPAL INVESTIGATOR: Udo Rudloff, M.D  
 
STUDY TITLE: 
Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial 
 
Continuing Review Approved by the IRB on 9/23/13 
 
 
 
 
Amendment Approved by the IRB on 11/15/12 (E)  
 
Date Posted to Web: 10/4/13   
Standard 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY 
 
•   Adult Patient or    •   Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent (1) 
 
 
INTRODUCTION 
 
We invite you to take part in a research study at the National Institutes of Health (NIH). 
 
First, we want you to know that: 
 
 
Taking part in NIH research is entirely voluntary. 
 
 
You may choose not to take part, or you may withdraw from the study at any time.  In either case, 
you will not lose any benefits to which you are otherwise entitled.  However, to receive care at the 
NIH, you must be taking part in a study or be under evaluation for study participation. 
 
 
You may receive no benefit from taking part.  The research may give us knowledge that may help 
people in the future. 
 
Second, some people have personal, religious or ethical beliefs that may limit the kinds of medical or 
research treatments they would want to receive (such as blood transfusions).  If you have such beliefs, 
please discuss them with your NIH doctors or research team before you agree to the study. 
 
Now we will describe this research study.  Before you decide to take part, please take as much time as 
you need to ask any questions and discuss this study with anyone at NIH, or with family, friends or your 
personal physician or other health professional. 
 
Why is this study being done? 
 
Pancreas cancer is the fourth leading cause of cancer death in the United States. Surgery offers the only 
chance at cure however, by the time most patients are diagnosed with pancreas cancer their tumors are too 
large to be removed.  Standard intravenous chemotherapy may shrink some of the tumor, but even with 
chemotherapy, only about 25% of patients will live for one year following diagnosis. Researchers have 
been studying different ways of giving chemotherapy which will be more effective at shrinking the cancer 
so that it is small enough to be surgically removed.  Several phase 1 studies have shown that 
administration of chemotherapy directly into the pancreas in the area of the tumor is safe. Studies have 


 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 11-C-0099 
 
 
 
 
CONTINUATION:  Page 2 of 9 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent 
 
also shown that giving gemcitabine over a longer period of time increases the amount of drug that is 
available to the tumor. In this study, we plan to give gemcitabine (a chemotherapy approved to treat 
pancreas cancer) directly into the pancreas in the area of the cancer and at a slow rate of infusion.  Giving 
the gemcitabine directly to the tumor and at a slow rate of infusion is an experimental treatment and we are 
looking to find the safest dose of gemcitabine to give patients and also to see how well patients tolerate the 
drug given in this manner.  
 
Why are you being asked to take part in this study? 
 
You are being asked to participate in this study because you have pancreas cancer which is currently too 
large to be removed but has not yet spread to other organs that are not near your pancreas. 
 
 
How many people will take part in this Study? 
 
Up to 46 subjects will be enrolled here at the National Institutes of Health for this initial study. 
 
Description of Research Study 
 
This is an intra-inter patient dose escalation study (see below*) of gemcitabine given at a slow rate of 
infusion through a catheter which is threaded into one of the blood vessels in the pancreas and connected 
to a conventional vascular access device (port).  Subjects who meet the eligibility criteria will undergo 
pancreatic angiography and embolization (see During the Study for a description of angiography and 
embolization) as necessary to isolate the blood vessels supplying the tumor.  Subjects will receive up to 3 
courses (6 months) of Gemcitabine given through this catheter directly into the pancreatic circulation.  
The dose for each subject will be increased at the beginning of each cycle until the maximum dose is 
reached provided no dose limiting toxicities were experienced. Subjects will be assessed every 8 weeks to 
see if the tumor is shrinking. 
 
*intra-inter patient dose escalation study – a study where each group  (cohort)  of 3-6 patients enrolled in 
the study receives a higher dose of medication than the previous group unless 2 of 6 patients have a dose 
limiting toxicity (DLT – a specified list of side effects.)  In addition, patients in each cohort who do not 
experience a DLT, will receive a higher dose with each cycle of chemotherapy until the maximum dose is 
reached.   
 
Birth Control 
 
If you are a woman who is breast feeding or pregnant, you may not take part in the study because we 
don’t know how this medicine would affect your baby or your unborn child. If you are a woman who can  
become pregnant, or are the partner of a woman who can become pregnant, you will need to practice an 
effective form of birth control before starting study treatment, during study treatment, and for six (6) 
months after you finish study treatment.  If you think that you or your partner is pregnant, you should tell 
your study doctor or nurse at once.   


 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 11-C-0099 
 
 
 
 
CONTINUATION:  Page 3 of 9 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent 
 
Effective forms of birth control include  
• 
Abstinence  
• 
intrauterine device (IUD) 
• 
hormonal [birth control pills, injections, or implants] 
• 
tubal ligation 
• 
vasectomy 
 
What will happen if you take part in this research study?   
 
Before you begin the study 
You will have a history and physical examination, and your recent lab work and imaging studies will be 
reviewed to see if you are eligible for the study and to see if it is safe for you to be in this study.  If you 
haven’t had recent blood work or imaging studies, they will be repeated. If the exact size and location of 
your tumor is not clear on the MRI or CT scan, you will have a laparoscopy performed to be sure that you 
are eligible for the study. This is a minor surgical procedure that uses a laparoscope, inserted through the 
abdominal wall, to examine the inside of the abdomen. A laparoscope is a thin, tube-like instrument with 
a light and a lens for viewing. It may also have a tool to remove tissue to be checked under a microscope 
for signs of disease. 
 
During the study 
Within about two weeks following your initial evaluation visit, you will be admitted to the NIH Clinical 
Center patient care unit and will undergo pancreatic angiography and embolization.  This procedure is 
performed in the Interventional Radiology (IR) Suite by a radiologist while you are under either general 
or local anesthesia with sedation.  The radiologist will thread a catheter (long thin flexible plastic tube) 
through the femoral artery (in your groin) to the blood vessels supplying the pancreas.  He will then inject 
dye into the catheter and take x-rays in order to see the blood circulation to the tumor, the pancreas and 
other nearby organs (angiogram).  In order to separate the blood flow to the tumor from the blood flow to 
the other organs, he will embolize or close off, vessels that supply both the tumor and the other organs. 
He will then thread another catheter into the main vessel that supplies the tumor.  The other end of the 
catheter will then be tunneled under your skin and attached to a conventional “port” under the skin in 
your hip. This will allow the medication to be given into the catheter throughout the course of treatment. 
If the catheter cannot be placed through the femoral artery due to the location of your tumor and/or the 
shape of your blood vessels, then the catheter may be placed through one of the blood vessels in your 
neck or arm and the port will be placed in your chest – like a conventional port.  After you have 
completed treatment the port will be removed.  The whole procedure takes approximately 2 hours to 
complete. The principle investigator will review the procedure with you and you will be asked to sign an 
additional consent for the treatment.  
 
After the catheter has been inserted, you will be monitored over night in the intensive care unit (ICU).  
The following morning, you will return to the IR suite to start your first dose of chemotherapy.  The 
radiologist will inject dye and take x-rays to be sure the catheter is in the correct place.  If it is not – he 
will re position it.  A special needle will be inserted into the port and the gemcitabine in fusion will be 


 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 11-C-0099 
 
 
 
 
CONTINUATION:  Page 4 of 9 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent 
 
started.  Once the physicians are certain you are tolerating the infusion, you will return to the ICU for the 
rest of the infusion – 24 hours total. During the infusion you will be monitored, have blood drawn at least 
once daily and received routine care.  In order to prevent blood clots from forming in or around the 
catheter you will be placed on a blood thinner given by injection.  The nurses on the patient care unit will 
instruct you on how to give the injections before you are discharged.  
 
Once you are discharged, you will need to have blood drawn weekly (this may be done by your home 
oncologist) and we will give you a diary to record any side effects from the treatment and your blood 
thinner doses. If you do not return to the Clinical Center to have blood drawn, the research nurse will 
contact you and ask you about any side effects you may be having.    
 
Two weeks after the first infusion, you will return to the Clinical Center every two weeks to receive your 
second, third and fourth infusions.   Prior to each infusion the research nurse or physician will review 
your diary, you will have a physical exam, lab work and another angiogram, CT, or x-ray performed to 
check the placement of the catheter. You may receive the second (and subsequent) infusions in the ICU or 
on the patient care unit.  Your will be monitored during the infusions and have labs drawn and receive 
standard care as needed. If you tolerated the second infusion without experiencing any DLTs your dose 
will be increased for the third and fourth infusions.  Once you are discharged you will have blood drawn 
and complete your diary as noted above. If you have abdominal pain or other GI symptoms following 
your treatments, you will have an endoscopy prior to your next treatment to be certain that it is safe for 
you to continue treatment.   An endoscopy is similar to a laparoscopy except that a flexible tube is 
inserted through your esophagus and into your stomach to look for signs of bleeding or irritation  
 
Two weeks after the fourth treatment (course 1) you will return to the Clinical Center for imaging studies, 
a physical examination and lab work.  If your tumor is shrinking you will continue with treatment for 2 
more courses. If at any time your tumor becomes small enough to be surgically removed, your physician 
will discuss this option with you.  
 
When you are finished taking the treatments 
You will be seen in the clinic every 3 months for 2 years following your last treatment and then every 6 
months.  At each evaluation you will have a physical examination, blood work drawn and imaging 
studies.  If you are unable or un-willing to return to the Clinical Center for follow up visits, the research 
nurse will contact you by phone.  
 
What other choices do I have if I do not take part in this study?  
Instead of being in this study, you have these options: 
 
• 
Getting chemotherapy or surgery for your cancer without being in a study 
• 
Taking part in another experimental study 
• 
Getting comfort care, also called palliative care.  This type of care helps reduce pain, tiredness, 
appetite problems and other problems caused by the cancer.  It does not treat the cancer directly.  


 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 11-C-0099 
 
 
 
 
CONTINUATION:  Page 5 of 9 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent 
 
Instead, it tries to improve how you feel.  Comfort care tries to keep you as active and comfortable as 
possible. 
 
Please talk to your doctor about these and other options. 
 
Risks or Discomforts of Participation: What side effects or risks can I expect from being in this 
study?  
The risks involved in participating in this study have been summarized below according to each part of 
the experimental treatment.  Because gemcitabine has not been given in this way before, there may be 
additional risks that we do not know about.  
Pancreatic Angiography and Embolization 
Likely 
Less Likely 
Rare but Serious 
 Abdominal Pain (12-24 
hours) 
 Fever (99-102 degrees F) 
 Nausea and/or Vomiting 
 Abdominal Fluid Buildup 
(Ascites) 
 Bleeding (at catheter 
insertion site) 
 Infection (at catheter 
insertion site) 
 Allergy to Iodine Contrast 
agent 
 Mild pancreatitis 
 Liver Failure 
 Kidney Failure 
 Liver Abscess Formation 
 Stomach or Duodenal Ulcer 
 Pancreatitis - severe 
 Cholecystitis  
 Arterial Injury at catheter 
insertion site 
Gemcitabine 
Likely 
Less Likely 
Rare but Serious 
 Fatigue, may be due to  due to 
low red blood cell counts 
 Increased risk of infection 
due to low white blood cell 
counts 
 Bleeding due to low platelet 
counts 
 Mucositis (mouth sores) 
 Nausea and vomiting 
 
 Diarrhea  
 Rash 
 Change in lab values that may 
not cause any symptoms and 
may not require treatment 
 Liver damage 
 Kidney damage 
 
Indwelling catheter 


 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 11-C-0099 
 
 
 
 
CONTINUATION:  Page 6 of 9 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent 
 
Likely 
Less Likely 
Rare but Serious 
 Mild Pain (12-24 hours) 
 Infection  
 Formation of blood clots 
which could break off and 
travel to your legs and other 
organs 
 Pancreatitis 
 Bleeding  
lovenox 
Likely – at the site of 
injection 
Less Likely 
Rare but Serious 
 Mild irritation 
 Pain 
 Bruising 
 Redness  
 Change in lab values that may not 
cause any symptoms and may not 
require treatment 
 Hemorrhage or bleeding 
 
Are there benefits to taking part in this study? 
The aim of this study is to see if this experimental treatment will cause your tumors to shrink.  We hope 
that you will get personal medical benefit from taking part in this study, but we cannot be certain.  These 
potential benefits could include shrinkage of your tumor(s), possibly making your tumors small enough to 
be removed, lessening of your symptoms, such as pain, that are caused by the cancer or slowing the 
growth of your cancer.  Because there is little information about the giving gemcitabine at a slow rate 
directly to pancreas tumors, we do not know if you will benefit from taking part in this study (improved 
survival), although the knowledge gained from this study may help others in the future who have pancreas 
cancer. 
 
Research Subject’s Rights 
 
What are the costs of taking part in this study?  
If you choose to take part in the study, the following will apply, in keeping with the NIH policy: 
 
You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory 
testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for 
you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not 
available at the NIH.  
 


 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 11-C-0099 
 
 
 
 
CONTINUATION:  Page 7 of 9 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent 
 
There are limited funds available to cover the cost of some tests and procedures performed outside the 
Clinical Center, NIH.  You may have to pay for these costs even if they are not covered by your insurance 
company. 
 
Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, 
NIH. 
 
Once you have completed taking part in the study, medical care will no longer be provided by the Clinical 
Center, NIH. 
 
Stopping Study Participation  
Your doctor may decide to take you off of the study if he/she believes that it is in your best interest, if 
your disease does not respond to the treatment, if you have side effects that are too severe, or if new 
information shows that another treatment may be better for you.  In this case, you will be informed of the 
reason therapy is being stopped. You will also be counseled regarding other treatment options as in 
“Alternative Approaches or Treatments.” 
 
You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, 
we would like you to talk to the study doctor and your regular doctor first. 
Will your medical information be kept private?  
We will do our best to make sure that the personal information in your medical record will be kept private.  
However, we cannot guarantee total privacy.  Organizations that may look at and/or copy your medical 
records for research, quality assurance, and data analysis include: 
• 
The National Cancer Institute (NCI) and other government agencies, like the Food and Drug 
Administration (FDA), which are involved in keeping research safe for people. 
• 
National Cancer Institute Institutional Review Board 
A description of this clinical trial will be available on http://www.Clinicaltrials.gov, as required by U.S. 
Law.  This Web site will not include information that can identify you.  At most the Web site will include 
a summary of the results.  You can search this Web site at any time. 
Conflict of Interest 
 
The National Institutes of Health (NIH) reviews NIH staff researchers at least yearly for conflicts of 
interest.  The following link contains details on this process http://ethics.od.nih.gov/procedures/COI-
Protocol-Review-Guide.pdf.  You may ask your research team for a copy of the Protocol Review Guide or 
for more information.  Members of the research team who do not work for NIH are expected to follow 
these guidelines but they do not need to report their personal finances to the NIH. 
Members of the research team working on this study may have up to $15,000 of stock in the companies 
that make products used in this study.  This is allowed under federal rules and is not a conflict of interest.  


 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 11-C-0099 
 
 
 
 
CONTINUATION:  Page 8 of 9 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent 
 
 
OTHER PERTINENT INFORMATION 
1. Confidentiality.  When results of an NIH research study are reported in medical journals or at 
scientific meetings, the people who take part are not named and identified.  In most cases, the NIH will 
not release any information about your research involvement without your written permission.  However, 
if you sign a release of information form, for example, for an insurance company, the NIH will give the 
insurance company information from your medical record.  This information might affect (either 
favorably or unfavorably) the willingness of the insurance company to sell you insurance. 
 
The Federal Privacy Act protects the confidentiality of your NIH medical records.  However, you should 
know that the Act allows release of some information from your medical record without your permission, 
for example, if it is required by the Food and Drug Administration (FDA), members of Congress, law 
enforcement officials, or authorized hospital accreditation organizations. 
 
2. Policy Regarding Research-Related Injuries.  The Clinical Center will provide short-term medical 
care for any injury resulting from your participation in research here.  In general, no long-term medical 
care or financial compensation for research-related injuries will be provided by the National Institutes of 
Health, the Clinical Center, or the Federal Government.  However, you have the right to pursue legal 
remedy if you believe that your injury justifies such action. 
 
3. Payments.  The amount of payment to research volunteers is guided by the National Institutes of 
Health policies.  In general, patients are not paid for taking part in research studies at the National 
Institutes of Health.  Reimbursement of travel and subsistence will be offered consistent with NIH 
guidelines. 
 
4. Problems or Questions.  If you have any problems or questions about this study, or about your rights 
as a research participant, or about any research-related injury, contact the Principal Investigator, Udo 
Rudloff, M.D., Building 10, Room 4-5940, Telephone: 301-496-3098. 
You may also call the Clinical Center Patient Representative at 301-496-2626. 
 
5. Consent Document.  Please keep a copy of this document in case you want to read it again. 


 
  
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH 
STUDY 
   MEDICAL RECORD 
•  Adult Patient or    •  Parent, for Minor Patient 
 
STUDY NUMBER: 11-C-0099 
 
 
 
 
CONTINUATION:  Page 9 of 9 
 
PATIENT IDENTIFICATION 
CONSENT TO PARTICIPATE IN A CLINICAL 
 
RESEARCH STUDY (Continuation Sheet) 
 
•  Adult Patient or   •  Parent, for Minor Patient 
 
NIH-2514-1 (07-09) 
 
P.A.: 09-25-0099 
 
File in Section 4:  Protocol Consent 
 
 
COMPLETE APPROPRIATE ITEM(S) BELOW: 
 
A. Adult Patient’s Consent 
B. Parent’s Permission for Minor Patient. 
I have read the explanation about this study and have 
been given the opportunity to discuss it and to ask 
questions.  I hereby consent to take part in this study. 
I have read the explanation about this study and have 
been given the opportunity to discuss it and to ask 
questions.  I hereby give permission for my child to 
take part in this study.   
(Attach NIH 2514-2, Minor’s Assent, if applicable.) 
 
  
 
 
  
 
Signature of Adult Patient/ 
Legal Representative 
Date 
 
 
 
Print Name 
Signature of Parent(s)/Guardian 
Date 
 
 
 
Print Name 
C. Child’s Verbal Assent (If Applicable) 
The information in the above consent was described to my child and my child agrees to participate in the 
study. 
 
 
 
  
 
 
 
 
Signature of Parent(s)/Guardian 
Date 
 
Print Name 
THIS CONSENT DOCUMENT HAS BEEN APPROVED FOR USE  
FROM SEPTEMBER 23, 2013 THROUGH SEPTEMBER 22, 2014. 
 
 
 
  
 
 
  
 
Signature of Investigator 
Date 
 
 
 
Print Name 
Signature of Witness 
Date 
 
 
 
Print Name 
 

Prot_000.pdf: 
X
X
Dawn Roy    AM E
11/19/12