NCT04923178 A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
| NCT ID | NCT04923178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Urothelial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2022-10-24 |
| Primary Completion | 2041-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,100 participants in total. It began in 2022-10-24 with a primary completion date of 2041-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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....
Eligibility 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
Contact & Investigator
Andrea B Apolo, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT04923178 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04923178 currently recruiting?
Yes, NCT04923178 is actively recruiting participants. Contact the research team at tzu-fang.wang@nih.gov for enrollment information.
Where is the NCT04923178 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04923178 clinical trial?
NCT04923178 is sponsored by National Cancer Institute (NCI). The principal investigator is Andrea B Apolo, M.D. at National Cancer Institute (NCI). The trial plans to enroll 1,100 participants.
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