NCT02379429Recruiting
Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue
Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens From Healthy Volunteers and Urothelial Cancer Patients
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 4 Mar 2015
- Start date
- 10 Nov 2015
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Bladder cancer
- NCT number
- NCT02379429
What you commit to
- Study type: Observational
- Planned participants: 500
- From 10 Nov 2015 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other illness
- Subjects co-morbidities preclude diagnostic or therapeutic intervention. Co-morbidities include:
- --Ongoing treatment for another non-skin malignancy.
- 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.
Other
- Subjects who are pregnant.
- Subjects who are pregnant.
- Healthy volunteers who are family members with germline mutations.
Who the study is looking for
- -Adults (greater than or equal to 18 years of age) and able to give informed consent.
Criteria the registry did not label
- INCLUSION CRITERIA FOR UROTHELIAL CANCER PARTICIPANTS:
- Adults (\>= 18 years of age) with biopsy-proven or suspected urothelial cancer who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
- ECOG performance status of 0-3.
- Must be willing and able to provide informed consent.
Age in the registry: 18 years to 120 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.