Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923178
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2021-06-10
Brief Title:
A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
Status:
RECRUITING
Status Verified Date:
2024-10-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 genitourinary GU tract include bladderurachal 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 rare GU tract malignancies
Eligibility
-Participants 18 years of age diagnosed with urothelial or rare GU tract malignancies
Design
This will be a long-term multi-center 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 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
Rare histological variants of the genitourinary GU tract include bladderurachal 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 rare GU tract malignancies
Eligibility
-Participants 18 years of age diagnosed with urothelial or rare GU tract malignancies
Design
This will be a long-term multi-center 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000302-C | None | None | None |