Understanding Urothelial and Rare Genitourinary Cancers
A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
National Institutes of Health Clinical Center (CC) · NCT04923178
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 |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT04923178 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with urothelial or rare genitourinary cancers.
Not a fit: Patients without a confirmed diagnosis of urothelial or rare genitourinary cancers may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urothelial Cancer, Bladder Cancer, Genitourinary Cancer, Urogenital Neoplasms, Urogenital Cancer, bladder/urachal adenocarcinoma, renal tumors, penile cancers