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Observational Study of Urothelial Cancer Tissue

This observational study aims to better understand urothelial cancer (cancer of the bladder, ureter, and urethra) by looking at changes in cells and genes. Researchers want to compare normal tissue with tumor tissue to learn how these changes might predict how the disease progresses and how people respond to treatment. There are no specific interventions or drugs being tested in this study. You may be able to join if you are an adult (18 or older) with biopsy-proven or suspected urothelial cancer, or if you have an inherited condition that increases your risk for bladder cancer. The main goal is to collect samples to study the molecular causes of urothelial cancer. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 500 participants, including those with urothelial cancer and healthy volunteers.
What's involved
Participants will have a physical exam, and their medical records and tissue samples will be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Samples will be collected for ongoing study of molecular mechanisms.

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NCT02379429

Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue

Recruiting
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~500 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in urothelial cancer.
Measured over ongoing

Conditions

Bladder Cancer
Urinary Tract Cancer
Urothelial Cancer
Healthy Volunteers

Explore related trials

Healthy VolunteersUrothelial Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Raju R Chelluri, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Lidenys C O'Brien Gutierrez
lidenys.o'[email protected]
(240) 858-7481
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Adults (greater than or equal to 18 years of age) and able to give informed consent.

Exclusion

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.
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.

What this trial measures

  • Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in urothelial cancer.ongoing

    Collection of blood, urine, saliva, and/or benign and malignant tissue