Understanding Urothelial Cancer through Tissue Collection
Official title: Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens From Healthy Volunteers and Urothelial Cancer Patients
Run by National Institutes of Health Clinical Center (CC) · NCT02379429 · Data updated 2026-11-12
This study is collecting tissue and other samples from people with urothelial cancer to see how the disease works and to help find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | November 10, 2015 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2028 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT02379429 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who have or are suspected of having urothelial cancer.
✕Probably not a fit
Patients who are pregnant or have co-morbidities that prevent diagnostic or therapeutic intervention may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to collect and analyze tissue samples from patients with urothelial cancer to better understand the genetic and molecular changes associated with the disease. Participants will provide tumor tissue blocks, blood, urine, and saliva samples, which will be used to identify differences between normal and cancerous tissues. The research focuses on the potential development of targeted therapies and predictive biomarkers for urothelial cancer. Healthy volunteers will also contribute samples for comparison purposes.
Why it matters
Potential benefit: If successful, this research could lead to new treatment strategies and improved outcomes for patients with urothelial cancer.
How similar studies have gone: Other studies focusing on the genetic basis of cancers have shown success in identifying new treatment pathways, suggesting this approach has potential.
Who can join: the full rules
Show full inclusion / exclusion criteria
* 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. EXCLUSION CRITERIA: * 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's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Raju R Chelluri, M.D. — National Cancer Institute (NCI)
- Study coordinator: Lidenys C O'Brien Gutierrez
- Email: lidenys.o'brien@nih.gov
- Phone: (240) 858-7481
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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BL-M07D1: T-bren vs standard platinum chemo for HER2-expressing metastatic urothelial cancer after anti-PD-(L)1 therapy
This trial tests whether T-bren can help people with HER2-expressing metastatic urothelial cancer who progressed after anti-PD-(L)1 therapy, compared with standard platinum-based chemotherapy.
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Datopotamab deruxtecan plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin for advanced or metastatic urothelial carcinoma
This trial will test whether datopotamab deruxtecan with carboplatin or cisplatin works better than gemcitabine with carboplatin or cisplatin for people with advanced urothelial carcinoma who progressed during or after enfortumab vedotin plus pembrolizumab.
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Understanding Urothelial and Rare Genitourinary Cancers
This study is trying to learn more about urothelial and rare genitourinary cancers by gathering health information and samples from adults who have been diagnosed with these cancers.
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Sacituzumab govitecan plus enfortumab vedotin for metastatic urothelial cancer
This trial tests whether combining sacituzumab govitecan and enfortumab vedotin, with pembrolizumab in some patients, helps people with metastatic urothelial carcinoma who have progressed after platinum chemotherapy and PD‑1/PD‑L1 inhibitors.
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Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.