Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
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|ClinicalTrials.gov Identifier: NCT04923178|
Recruitment Status : Not yet recruiting
First Posted : June 11, 2021
Last Update Posted : September 16, 2021
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.
To learn more about urinary tract cancers.
People ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.
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.
|Condition or disease|
|Urothelial Cancer Bladder Cancer Genitourinary Cancer Urogenital Neoplasms Urogenital Cancer|
Rare histological variants of the GU tract include bladder/urachal adenocarcinoma, squamous cell carcinoma, and small cell carcinoma; variants of urothelial carcinoma including plasmacytoid, sarcomatoid; renal tumors including sarcomatoid renal cell carcinoma and renal medullary carcinoma; penile cancers; micropapillary, giant cell, lipid rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns; small cell neuroendocrine carcinoma of the prostate, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC.
Some GU tumors occur so infrequently that they are not systematically captured by currently available registries, treatment protocols or tissue banks. The rarity of these tumors limits the sufficient numbers of patients needed in larger randomized clinical studies to characterize standard treatments or disease course.
Systematic and longitudinal collection and annotation of clinical history, tissue samples, imaging studies, participant reported outcomes, and other pertinent information in participants with these rare tumors will yield future knowledge and help with the development of subsequent prospective studies to optimize diagnosis and treatment paradigms for less common GU tumors.
Characterization of the natural history of urothelial and rare GU tract malignancies
Participants >= 18 years of age diagnosed with urothelial and rare GU tract malignancies.
This will be a long-term study to comprehensively study participants with rare GU tumors
Medical history will be collected and participants followed throughout the course of their illnesses, with particular attention to patterns of disease presentation, recurrence and progression, response to therapies, duration of responses and participant reported outcomes.
Tissue samples and blood will be obtained from participants during this study.
Broad spectrum of scientific experiments, including genomics and immune monitoring will be performed.
We anticipate accruing 1000 participants on this protocol
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies|
|Estimated Study Start Date :||September 21, 2021|
|Estimated Primary Completion Date :||December 1, 2041|
|Estimated Study Completion Date :||December 1, 2042|
1/Non-invasive urothelial cancer
Participants with high-grade and, low-grade non-invasive bladder cancer
2/Muscle invasive bladder and high-grade upper tract urothelial cancer
Participants with muscle invasive bladder and invasive upper tract urothelial cancer
3/Variant urothelial cancer
Participants diagnosed with a urothelial variant histologies at any stage
4/Metastatic Urothelial cancer
Participants diagnosed with urothelial cancer who cannot be placed in cohorts 1-3
5/Localized rare genitourinary tumors
Participants with localized rare genitourinary tumors treated with curative intent
6/Locally advanced and metastatic rare genitourinary tumors
Participants with locally advanced and metastatic rare genitourinary tumors
- natural history of urothelial and rare genitourinary cancer [ Time Frame: ongoing ]clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923178
|Contact: Olena Sierra Ortiz||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Andrea B Apolo, M.D.||National Cancer Institute (NCI)|