Collects tissue and samples from people with urothelial cancer and healthy volunteers
Collects tumor tissue, blood, urine and saliva from adults with bladder cancer.
Plain-language title generated from the registry record
Registry title: Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue
Key facts
- Where
- Bethesda, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT02379429, who can take part
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Institute (NCI)
- Trial code
- NCT02379429
- Record updated
- 16 October 2026
- Original description
Background:Read full original descriptionShow less
Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens From Healthy Volunteers and Urothelial Cancer Patients
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.
Inclusion: -Adults (greater than or equal to 18 years of age) and able to give informed consent.
Exclusion: 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; 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; Subjects who are pregnant; Subjects who are pregnant; Healthy volunteers who are family members with germline mutations.
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.