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

Background:

• Histological variants of the genitourinary (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 renal cell carcinoma (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, 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.

Objective:

-Characterization of the natural history of urothelial and GU tract malignancies.

Eligibility:

-Participants >= 18 years of age diagnosed with urothelial or GU tract malignancies.

Design:

• This will be a long-term multi-center study to comprehensively study participants with 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, and duration of responses.
• Tissue samples and blood will be obtained from participants during this study.
• A broad spectrum of scientific experiments, including genomics and immune monitoring will be performed.
• We anticipate accruing 1000 participants on this protocol.

• 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