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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04923178
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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....

Key Dates

Start date
Oct 24, 2022
Status verified
Jun 2026
Primary completion
Dec 1, 2041
Completion
Dec 1, 2042

Study Design

Enrollment
1,100 participants (estimated)

Arms

  • Arm: 1 / Urothelial cancer
    Participants with urothelial cancer.
  • Arm: 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.
  • Arm: 3 / Urothelial Carcinoma Variants
    Participants diagnosed with a urothelial variant histologies at any stage.
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

Find similar trials in Bethesda, MD

By condition
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By specialty
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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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