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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 : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date June 10, 2021
First Posted Date June 11, 2021
Last Update Posted Date October 27, 2021
Estimated Study Start Date November 1, 2021
Estimated Primary Completion Date December 1, 2041   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2021)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
Official Title Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
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.

Detailed Description

Background:

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.

Objective:

Characterization of the natural history of urothelial and rare GU tract malignancies

Eligibility:

Participants >= 18 years of age diagnosed with urothelial and rare GU tract malignancies.

Design:

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population primary clinical
Condition
  • Urothelial Cancer
  • Bladder Cancer
  • Genitourinary Cancer
  • Urogenital Neoplasms
  • Urogenital Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 10, 2021)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2042
Estimated Primary Completion Date December 1, 2041   (Final data collection date for primary outcome measure)
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 subject to understand and the willingness to sign a written informed consent

document.

EXCLUSION CRITERIA:

-Pregnancy

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Olena Sierra Ortiz (240) 858-3185 olena.sierraortiz@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04923178
Other Study ID Numbers 10000302
000302-C
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor National Cancer Institute (NCI)
Collaborators Not Provided
Investigators
Principal Investigator: Andrea B Apolo, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 9, 2021