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

NCT04923178 | Recruiting

• 2 other identifiers: 10000302000302-C
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• natural history of urothelial and rare genitourinary cancer

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

  ongoing

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary clinical

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urogenital Neoplasms; Urachal adenocarcinoma; Carcinoma, Renal Cell; Penile Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Kidney Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Penile Diseases

Study Officials

• Andrea B Apolo, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu-Fang Wang, R.N.

CONTACT

(240) 858-3236; tzu-fang.wang@nih.gov

Andrea B Apolo, M.D.

CONTACT

(301) 480-0536; apoloab@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 11, 2021
• Study Start: October 24, 2022
• Primary Completion (Estimated): December 1, 2041
• Study Completion (Estimated): December 1, 2042
• Last Updated: January 26, 2026

Record last verified: 2026-01-21

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians

Locations

US (1)