Observational Study of Urothelial and Rare Genitourinary Cancers

This study aims to understand more about common and rare cancers that affect the urinary and reproductive systems (genitourinary tract), such as bladder, kidney, testicular, and prostate cancers. Researchers want to collect information about people with these cancers, especially those that are very rare and not often included in other studies. By gathering medical history and reviewing records, the study hopes to learn about the natural course of these diseases. This information can help develop better ways to diagnose and treat these cancers in the future. The study is open to individuals aged 18 and older who have a confirmed diagnosis of urothelial or rare genitourinary cancer.

Study design
This is an observational study, meaning no specific treatments are being tested. It plans to enroll about 1100 participants.
What's involved
You will be screened with questions about your medical history, and your medical records will be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The natural history of these cancers will be measured on an ongoing basis.

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NCT04923178

A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies

Recruiting
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~1,100 participants
Updated 2026-08-10 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
natural history of urothelial and rare genitourinary cancer
Measured over ongoing
Urothelial Cancer
Bladder Cancer
Genitourinary Cancer
Urogenital Neoplasms
Urogenital Cancer
1 sites across 1 states
Maryland1
  • Andrea B Apolo, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

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Eligibility criteria

Inclusion

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

None
  • natural history of urothelial and rare genitourinary cancerongoing

    clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival