Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue
Recruiting now
Conditions studied: Bladder Cancer, Urinary Tract Cancer, Urothelial Cancer, Healthy Volunteers
In brief
Background: Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better understand what changes in a person s cells and genes cause this cancer to form. This may help them find new ways to treat it. Objective: \- To perform DNA sequencing to help researchers learn the differences between normal tissue and tumor tissue. Also, to learn how molecular changes - including gene changes - might help predict the course of disease and how people respond to therapy. Eligibility: \- Adults age 18 and older who have or are suspected of having urothelial cancer or an inherited disorder that raises their risk of getting bladder cancer. Design: * Participants will be screened with a physical exam. Their medical records and tissue samples will be reviewed. * Eligible participants will give tissue blocks of their original tumor. The blocks will be put in a tissue bank. * Participants medical records may be reviewed. * Participants may have a medical history and physical exam. * Participants may have blood and urine tests. They may have imaging scans. They may give urine, blood, and saliva samples. These samples may be used in future research. * If participants need surgery for their cancer, researchers will keep some of the tissue (both tumor and normal tissue). The tissue may be used in future research. * Participants will go back to the Clinical Center in 6 months. They may give saliva, urine, and blood samples. After 6 months, they will be seen by their local doctor for standard post-surgical visits. * Participants will be called every 6 months to give health updates.
Key facts
- Study ID
- NCT02379429
- Run by
- National Cancer Institute (NCI)
- People needed
- 500
- Starts
- 2015-11-10
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adults (greater than or equal to 18 years of age) and able to give informed consent.
- EXCLUSION CRITERIA:
- Subjects who are pregnant.
- Diagnosis of cancer requiring treatment other than minor resection of basal cell or squamous cell skin cancers.
- Heart, lung, kidney disease, or other medical conditions as per Principal Investigator discretion.
- History of acute or chronic hepatitis B/C or HIV infection. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.
- Healthy volunteers who are family members with germline mutations.
You may not qualify if…
- Subjects who are pregnant.
- Subjects co-morbidities preclude diagnostic or therapeutic intervention. Co-morbidities include:
- -Ongoing treatment for another non-skin malignancy.
- History of hepatitis B/C or HIV. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.
- ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS
- INCLUSION CRITERIA:
- Adults (greater than or equal to 18 years of age) and able to give informed consent.
- EXCLUSION CRITERIA:
- Subjects who are pregnant.
- Diagnosis of cancer requiring treatment other than minor resection of basal cell or squamous cell skin cancers.
- Heart, lung, kidney disease, or other medical conditions as per Principal Investigator discretion.
- History of acute or chronic hepatitis B/C or HIV infection. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.
- Healthy volunteers who are family members with germline mutations.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.