Actively Recruiting

Age: 18Years +
All Genders
NCT04923178

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

Led by National Cancer Institute (NCI) · Updated on 2026-01-26

1100

Participants Needed

1

Research Sites

1049 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have confirmed urothelial or rare genitourinary cancer, including but not limited to 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 histologic variants such as micropapillary, giant cell, lipid-rich, clear cell, nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma, mixed patterns, 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 or older
  • Ability to understand and willingness to sign a written informed consent document
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

T

Tzu-Fang Wang, R.N.

CONTACT

A

Andrea B Apolo, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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