Clinical trial: NCT02197897
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Potential Risks And Discomforts

Blood draw- Inserting needles into veins for collecting blood may be uncomfortable.  Risks include slight bruising at the injection site, fainting, the formation of a small blood clot or swelling of the vein and surrounding tissue, bleeding from the site, and the remote possibility of infection at the site of the needle puncture.  Fainting is usually harmless, of short duration, and typically produces feelings of weakness, sweating, slowing of the heart rate and an abnormal decrease in blood pressure. Care will be taken to avoid these complications. Cystoscopy-  The discomfort is nearly identical to being catheterized, which generally causes slight to moderate discomfort. There will be a feeling of fullness in the bladder and a sensation to empty during the cystoscopy examination.  Infection or bladder irritation may also occur.Biopsy (removal of small amount of tissue) of the bladder requires an anesthetic (numbing jelly) and there may be some bleeding afterwards for 1-5 days. The discomfort is nearly identical to being catheterized, which generally causes slight to moderate discomfort. There will be a feeling of fullness in the bladder and a sensation to empty G v8 9May2017 Amend 9May2017 Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals H-25233 Phase II Trial of Estrogen Receptor Targeted Treatment of Non-Invasive Bladder Cancer H-25233-  PHASE II TRIAL OF ESTROGEN RECEPTOR TARGETED TREATMENT OF
NON-MUSCLE INVASIVE BLADDER CANCER WITH TAMOXIFEN
during the cystoscopy examination. Infection or bladder irritation may also occur.  
The risks associated with leaving a tumor in the body for study purposes are minimal as there is a low rate of progression. The Marker Lesion Trial study design consists of deliberately leaving a small visible lesion in the bladder so the patient can receive the study treatment , and shortly afterward have the lesion removed, them re-assess how effective the treatment. Marker Lesion Trial is the design of choice.The period of observation between the biopsy and the final treatment is very short and not receiving the standard mitomycin-C is considered safe.  
The loss of confidentiality regarding research information is a possibility, although, the risk is low. The investigator and his staff will make every effort to maintain the confidentiality Adverse effects of tamoxifen citrate usually are relatively mild and rarely severe enough to necessitate discontinuance of the drug in patients with breast cancer.  Tamoxifen usually is well tolerated in male patients with breast cancer. Pregnancy Warning: It is possible that the biopsy procedure could injure a fetus if you are pregnant.  
Because of the potential risks involved, you should not become pregnant while you are participating in this study. If you are sexually active or become sexually active and can get pregnant, females and their male partners must agree to use a double barrier method of birth control (use two forms of highly effective contraception at the same time such as  birth control pills and condoms ) every time you have sex between the first biopsy and the second biopsy (about 4 weeks): oral contraceptives ("the pill"),
- intrauterine devices (IUDs), - contraceptive implants under the skin, or contraceptive injections,
- condoms with foam.  
There may be a risk of reactions to tamoxifen in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.  
There may be a risk of blood clots forming and moving within the veins or arteries such as a deep vein blood clot, stroke or a blood clot in the lung. There may be a risk of hot flushes (flashes) and or increased hot flushes (flashes).  
There may be a risk of an increase in fats or lipids in the blood while taking tamoxifen.  
There may be a risk of  increased fluid retention or edema.  
There may be a risk of vaginal discharge and or irregular menstrual cycles, loss of libido or impotence.  
There may be a risk of  muscle or bone pain.  
There may be a risk of vision changes.  
There may be a risk of changes in your liver blood tests.  
There may be a risk of nausea, changes in eating habits or abdominal cramps.  
There may be a risk of feeling dizzy, have a headache, feel tired or experience depression. There may be a risk of changes in your platelet count (a blood cell that helps blood to stop flowing from a cut)
There may be a risk hair thinning or hair loss.  
G v8 9May2017 Amend 9May2017 Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals H-25233 Phase II Trial of Estrogen Receptor Targeted Treatment of Non-Invasive Bladder Cancer H-25233-  PHASE II TRIAL OF ESTROGEN RECEPTOR TARGETED TREATMENT OF non-muscle invasive bladder cancer with tamoxifen There may be a risk of weight loss or a cough.  
There may be a risk of cancer in the lining of the uterus or of the liver or liver abnormalities. There may be a treatment or procedure that involve risks that are unforeseeable.  
These side effects are usually temporary and do not cause permanent damage. Study staff will update you in a timely way on any new information that may affect your decision to stay in the study.  There is a small risk for the loss of confidentiality. However, the study personnel will make every effort to minimize these risks.
Clinical trial: NCT02197897
Section: Procedures
Subsections: Procedures

The research will be conducted at the following location(s):
Baylor College of Medicine, Baylor St. Luke's Medical Center (BSLMC), HCHD: Harris County Hospital District Ben Taub, and TMH: The Methodist Hospital. Your participation in this study will last about 4 months.  
The first study visit is called the screening visit.  
After you have discussed this research study with the doctor and/or a member of his study team and if you agree to take part in this study, you will sign and date this consent form.  
You will have a physical exam and you will be asked about your medical history and what drugs you are now taking.  
If you are a female of child bearing potential, you will provide a urine sample to test for pregnancy. It will be documented in the Research Forms if the subject is post-menopausal or has had a hysterectomy. All subjects will be asked to use double barrier method of birth control (use two forms of birth control at the same time, such as birth control pills and condoms), including females who are not of child bearing potential.  
Approximately, two teaspoons of blood will be drawn for the analysis of Complete Blood Count, platelets (a blood cell that helps blood to stop flowing from a cut) and bilirubin (is a waste product of the G v8 9May2017 Amend 9May2017  
H-25233 Phase II Trial of Estrogen Receptor Targeted Treatment of Non-Invasive Bladder Cancer H-25233-  PHASE II TRIAL OF ESTROGEN RECEPTOR TARGETED TREATMENT OF non-muscle invasive bladder cancer with tamoxifen normal breakdown of red blood cells). If you have had labs drawn within two weeks prior to screening visit \#1, we may be able to use those results.  
A urine sample will be collected and tested for cancer cells.  
Visit 2 Visit 2 will occur 1-4 weeks after the screening visit. You will be asked about what medications you are taking. You will be given the study medication called Tamoxifen with instructions to take a single dose of 20 milligrams Tamoxifen by mouth in the evening every day  for 12 weeks. Tamoxifen will start on day 1 after 1st resection of marker lesion biopsy.  You will be given Tamoxifen Drug Instruction Sheet and Tamoxifen Subject Diary to record the day , date and time you take Tamoxifen.  
You will undergo a cystoscopy. A small, hollow tube with a light attached at the end will be inserted through the urethra (also known as the urinary channel) so that the doctor can see inside the bladder. The tube is about as wide as a wooden pencil. The urinary channel will be anesthetized
(feel numb) locally with a lubricating jelly. You will then have a bladder biopsy to remove a small piece of the tumor and some surrounding tissue. This procedure will be done in the Urology Clinic.  You will usually have a small amount of blood in your urine shortly after this procedure, as well as a burning sensation with and urinary frequency (having to pass urine often) that usually lasts for 1-5 days.  
The urine collected during the cystoscopy will be tested for cancer cells. Telephone Call - 3 Days after Visit 2 You will be asked about what medications you are taking and about the days and times you took Tamoxifen.  
You will be asked about how you are feeling generally and about any adverse events (changes to your body or how you are feeling since the screening visit). Visit 3-6 weeks after last telephone call You will be asked about what medications you are taking and be given Tamoxifen  to take a single dose of 20 milligrams Tamoxifen by mouth in the evening every day  for a total of 12 weeks.  
You will be asked about any adverse events (changes to your body or how you are feeling since the screening visit). Week 12- You will have another cystoscopy and bladder tumor biopsy 12 weeks after you begin taking the study medication so we can evaluate the effect of the medication .. A small, hollow tube with a light attached at the end will be inserted through the urethra (also known as the urinary channel) so that the doctor can see inside the bladder. The tube is about as wide as a wooden pencil. The urinary channel will be anesthetized
(numbed) with a lubricating jelly. You will then have a bladder biopsy to remove a small piece of G v8 9May2017 Amend 9May2017  
H-25233 Phase II Trial of Estrogen Receptor Targeted Treatment of Non-Invasive Bladder Cancer H-25233-  PHASE II TRIAL OF ESTROGEN RECEPTOR TARGETED TREATMENT OF NON-MUSCLE INVASIVE BLADDER CANCER WITH TAMOXIFEN
the tumor and some surrounding tissue. You will usually have a small amount of blood in your urine shortly after this procedure, as well as a burning sensation with and urinary frequency that usually lasts for 1-5 days.  
The 2nd procedure will involve a resection of the remaining marker lesion ( surgical removal of the remaining bladder tumor after taking Tamoxifen), and because is a larger procedure, it will happen at the Hospital as an outpatient procedure.  
The urine sample collected during the cystoscopy will be tested for cancer cells.  
These samples will not be banked for future use. If there is a remaining sample after the planned analyses are performed, these specimens will be kept until the completion of the study. At the end of the trial, these specimens will be destroyed in an appropriate manner.  
Telephone Call - 30 Days after Visit 3 (End of Study)
You will be asked about what medications you are taking and about the days and times you took Tamoxifen.  
You will be asked about how you are feeling generally and about any adverse events (changes to your body or how you are feeling since the screening visit).  
Follow-Up Visit: 3 Months Post- 2nd Resection 1. Office Visit 2. Cystoscopy &  Cytology The following exams are done at your doctors discretion and may be requested if your doctor thinks it medically necessary. 4. History/ Physical Exam 5. Labs (Hematology, CBC/Platelets, Urinalysis, Bilirubin).
Clinical trial: NCT02197897
Section: Withdrawal from Study
Subsections: Subject Withdrawal From A Study|Investigator Withdrawal Of Subject From A Study

If you decide to stop taking part in the study or if you are removed from the study, you may decide that you no longer allow protected health information that identifies you to be used in this research study. Contact the study staff to tell them of this decision, and they will give you an address so that you can inform the investigator in writing. The investigator will honor your decision.

The investigator or sponsor may decide to stop you from taking part in this study at any time.  You could be removed from the study for reasons related only to you (for example, if you move to another city, if you do not take your study medication, or if you have a serious reaction to your study medication) or because the entire study is stopped. The sponsor, investigator, Food and Drug Administration, or Institutional Review Board may stop the study at any time.