Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT04923178

Conditions

Urothelial Cancer

Bladder Cancer

Genitourinary Cancer

Urogenital Neoplasms

Urogenital Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors.

Objective:

To learn more about urinary tract cancers.

Eligibility:

People ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.

Design:

Participants will be screened with questions about their medical history. Their medical records will be reviewed.

Participants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions.

Participants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm.

Participants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like.

Participants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed.

Some blood and tumor samples may be used for genetic tests.

Participants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life....

Conditions

Urothelial Cancer

Bladder Cancer

Genitourinary Cancer

Urogenital Neoplasms

Urogenital Cancer

Study ID

NCT04923178

Start date

Oct 24, 2022

Status verified date

Aug 6, 2026

Completion date

Dec 1, 2042

Anticipated

Primary completion date

Dec 1, 2041

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

1100 participants

Anticipated

Interventions and Outcome Measures

Arms

1 / Urothelial cancer

Participants with urothelial cancer.

2 / Rare Bladder or Urinary Tract Histology

Participants with small cell carcinoma, adenocarcinoma, urachal squamous cell carcinoma, or pure sarcomatoid carcinoma. These pure histologies can occur in the bladder and/or urinary tract.

3 / Urothelial Carcinoma Variants

Participants diagnosed with a urothelial variant histologies at any stage.

4 / Rare GU Tumors

Participants with renal medullary carcinoma, testicular Sertoli or Leydig cell tumors, penile cancer, refractory germ cell tumors.

Primary outcome measure

  • natural history of urothelial and rare genitourinary cancer [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 10, 2026

Last verified

Aug 6, 2026

Keywords

  • bladder/urachal adenocarcinoma
  • renal tumors
  • penile cancers
  • small cell neuroendocrine carcinoma of the prostate
  • Renal Cell Carcinoma
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-10.