Clinical trial: NCT03648879
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?|Certificate Of Confidentiality

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 Institutes of Health Intramural 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.

To help us protect your privacy, we have obtained a Certificate of Confidentiality. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. You should also know that there are several circumstances in which the Certificate does not provide coverage. These include when information:  
- will be used for auditing or program evaluation internally by the NIH; or - must be disclosed to meet the legal requirements of the federal Food and Drug Administration (FDA).  
- is necessary for your medical treatment and you have consented to this disclosure;
- is for other research.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 18-C-0141 CONTINUATION: page 6 of 8 pages In addition, identifiable, sensitive information protected by this Certificate cannot be admissible as evidence or used for any purpose in any action, suit, or proceeding without your consent. You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information. The Certificate of Confidentiality will not protect against the required reporting by hospital staff of information on suspected child abuse, reportable communicable diseases, and/or possible threat of harm to self or others.
Clinical trial: NCT03648879
Section: Duration of Study Involvement
Subsections: Follow Up

Approximately 14 days after the endoscopy we would like to invite you to the Clinical Center to discuss results of these imaging procedures and check if you had any side effects from the procedure. If you are not able to come, we can do this over the phone. If you undergo subsequent gastrectomy (removal of the stomach), we will collect stomach tissue for confirmation of cancer diagnosis. Risks or Discomforts of Participation Risks associated with endoscopy **and biopsy:**
discomfort in your throat,  
bleeding, perforation, infection.
Risks associated with general anesthesia:
temporary confusion and memory loss,  
dizziness, difficulty passing urine, bruising or soreness from the IV drip, nausea, vomiting, shivering and feeling cold, sore throat, heart attack, pneumonia, stroke
Risks associated with fluorescein:  
nausea, vomiting, headache, dizziness,
fainting,  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 18-C-0141 CONTINUATION: page 4 of 8 pages low blood pressure
Clinical trial: NCT03648879
Section: Participant's Rights
Subsections: 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 interventions 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  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 18-C-0141 CONTINUATION: page 5 of 8 pages research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- 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 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.
Clinical trial: NCT03648879
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Additional Risks For Pregnant Women:|Potential Benefits Of Participation

loss of baby, premature labor and delivery.  
You should tell the doctors or nurses about any discomfort you may have. Care will be taken to avoid any complications

The aim of this study is to see if this experimental procedure will help us detect tumors better than we are currently able to. We do not know if you will receive personal, medical benefit from taking part in this study. These potential benefits could include detection of gastric cancer at its earliest stage so that it can be cured. Because there is not much information about the procedure's effect on cancer detection, we do not know if you will benefit from taking part in this study, although the knowledge gained from this study may help others in the future who have cancer.
Clinical trial: NCT03648879
Section: Procedures
Subsections: During The Study Endoscopy

Endoscopy, procedure to examine your esophagus and stomach, will be done under general anesthesia. Before imaging, we will do a physical examination, including weight and vital signs. During endoscopy a lighted tube will be inserted into your mouth and go down to the stomach. First, we will look at your stomach with regular device and then we will add the microscope.  
Before adding the microscope, we will inject you intravenously with a contrast agent called fluorescein. We will not use this agent if you are allergic to it or if you are a pregnant woman. During the procedure we will collect a small piece of tissue (biopsy) from the different areas of your stomach. The entire procedure will take about an hour, adding a half hour to a standard endoscopy. After the procedure, we will keep you for observation in the hospital for a few hours. If you live nearby and have someone to accompany you, you can go home on the same day. If you are traveling from a far then you may spend the night in the hospital prior to going discharge.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09) NIH-2514-2 (10-84) P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
  
STUDY NUMBER: 18-C-0141 CONTINUATION: page 3 of 8 pages
Clinical trial: NCT03648879
Section: Purpose of Research
Subsections: Why Is This Study Being Done?|Why Are You Being Asked To Take Part In This Study?

People with hereditary (passed from parent to child) gastric (stomach) cancer syndrome have a serious lifetime risk of developing cancer in their stomachs. Current international guidelines recommend that these people have regular endoscopies (a procedure using a small tube with a camera at the end that is passed through the throat and into the stomach) and biopsies (a sample of tissue is taken) even if their stomachs appear normal. However, this approach is not good enough to catch early signs of cancer, such as the appearance of tiny cancer cells that signal cancer development. In this study we will use an FDA approved small microscope attached to the endoscope to inspect the stomach lining and evaluate if this device is better than regular endoscopy 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)
STUDY NUMBER: 18-C-0141 CONTINUATION: page 2 of 8 pages in finding the first signs of cancer in the stomach. This special microscopic endoscopy will be performed in addition to the standard endoscopy that would normally be used to evaluate the stomach. The endoscopy itself is not investigational.

You are being asked to participate in this study because you have a personal or family history of a hereditary gastric cancer syndrome, OR you have a mutation that is known to lead to gastric cancer. How many people will take part in this study? Up to 40 people will take part in this trial.
Clinical trial: NCT03648879
Section: Withdrawal from Study
Subsections: Stopping Study Participation

Your doctor may decide to remove you from this study for the following reasons:
- If he/she believes that it is in your best interest  
- If he/she decides to close the study
In this case, you will be informed of the reason why you are being taken off this study. 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.  
If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, according to FDA guidelines, information collected on you up to that point may still be provided to NCI or designated representatives.