Understanding Urothelial and Rare Genitourinary Cancers
Official title: A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
Run by National Institutes of Health Clinical Center (CC) · NCT04923178 · Data updated 2026-11-12
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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1100 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | October 24, 2022 |
| Main results expected | December 1, 2041 |
| Study ends | December 1, 2042 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT04923178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older diagnosed with urothelial or rare genitourinary cancers.
✕Probably not a fit
Patients without a confirmed diagnosis of urothelial or rare genitourinary cancers 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 observational study aims to gather comprehensive data on the natural history of urothelial and rare genitourinary cancers, including various histological variants. Participants aged 18 and older with confirmed diagnoses of these cancers will undergo medical history screening, physical exams, and provide blood and urine samples. The study will also collect clinical photographs and family cancer history surveys to enhance understanding of these rare tumors and inform future treatment protocols.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients with rare genitourinary cancers.
How similar studies have gone: While there is limited data on similar studies due to the rarity of these cancers, the systematic approach of this study may provide valuable insights that have not been previously explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Participants must have histologically or cytologically confirmed urothelial or rare genitourinary cancer including but not limited to the following: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; any testicular cancer, sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors. Any genitourinary cancer can be included at the principal investigator's discretion. * Age \>=18 years. * Ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: -None
Where it's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Andrea B Apolo, M.D. — National Cancer Institute (NCI)
- Study coordinator: Tzu-Fang Wang, R.N.
- Email: tzu-fang.wang@nih.gov
- Phone: (240) 858-3236
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
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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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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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Understanding Urothelial Cancer through Tissue Collection
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.
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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.