A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
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| ClinicalTrials.gov Identifier: NCT04923178 |
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Recruitment Status :
Recruiting
First Posted : June 11, 2021
Last Update Posted : January 25, 2023
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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....
| Condition or disease |
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| Urothelial Cancer Bladder Cancer Genitourinary Cancer Urogenital Neoplasms Urogenital Cancer |
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 multi-center 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 |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies |
| Actual Study Start Date : | October 24, 2022 |
| Estimated Primary Completion Date : | December 1, 2041 |
| Estimated Study Completion Date : | December 1, 2042 |
| Group/Cohort |
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1 / Urothelial cancer
Participants with urothelial cancer.
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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.
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3 / Urothelial Carcinoma Variants
Participants diagnosed with a urothelial variant histologies at any stage.
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4 / Rare GU Tumors
Participants with renal medullary carcinoma, testicular Sertoli or Leydig cell tumors, penile cancer, refractory germ cell tumors.
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- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
- 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
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: Tzu-Fang Wang, R.N. | (240) 858-3236 | tzu-fang.wang@nih.gov | |
| Contact: Andrea B Apolo, M.D. | (301) 480-0536 | apoloab@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| 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) |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT04923178 |
| Other Study ID Numbers: |
10000302 000302-C |
| First Posted: | June 11, 2021 Key Record Dates |
| Last Update Posted: | January 25, 2023 |
| Last Verified: | January 21, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active. |
| Access Criteria: | Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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bladder/urachal adenocarcinoma renal tumors penile cancers |
small cell neuroendocrine carcinoma of the prostate Renal Cell Carcinoma Natural History |
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Urogenital Neoplasms Neoplasms Neoplasms by Site |