Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569316
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Genetic Testing for the Prevention of Cancer in Indigenous American Communities JUNIPER Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Journey to Understanding - Indigenous Peoples Engagement in Cancer Research Arizona JUNIPER
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is studying the genetic changes in cells associated with different types of cancer in Indigenous American IA populations in the Southwest to improve cancer screening precision prevention and therapeutic intervention for individual in these communities IA tribes have much lower rates of cancer screening have more limited access to healthcare are more often diagnosed at later stages of disease and have the poorest outcomes in all types of cancer when compared to any other racial and ethnic group in the United States Due to these significant cancer health disparities IAs have been understudied and little is known about the molecular characterization of tumors arising in IAs Undergoing genetic testing of tumors may improve cancer outcomes in IA participants and communities
Detailed Description:
PRIMARY OBJECTIVES
I To develop culturally appropriate respectful trusted and collaborative means to engage and recruit Indigenous Americans IAs affected by cancer newly diagnosed cancer participants participants undergoing cancer treatment and cancer survivors for molecular characterization of their tumors
Ia Conduct direct participant engagement with cancer participantssurvivors community advisors and partners to refine and optimize methodsprocesses
Ib Identify recruit and consent eligible IA cancer participantssurvivors Ic Implement tissue acquisition epidemiologic behavioral and clinical data collection conduct continuous assessment of performance benchmarks
Id Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select
SECONDARY OBJECTIVE
I Translate any discoveries to improved cancer screening precision prevention and therapeutic intervention that can be used to enhance cancer screening and precision prevention and improve cancer outcomes in Indigenous American participants and communities
OUTLINE
Patients undergo collection of blood or saliva samples on study for genetic testing Patients also undergo collection of leftover tissue obtained from standard of care SOC surgical procedure or biopsy or stored tissue samples for genetic testing on study Patients receive the results of their genetic testing and are given resources for counseling and further care
After completion of study intervention patients are followed up once a year up to 5 years from study registration
I To develop culturally appropriate respectful trusted and collaborative means to engage and recruit Indigenous Americans IAs affected by cancer newly diagnosed cancer participants participants undergoing cancer treatment and cancer survivors for molecular characterization of their tumors
Ia Conduct direct participant engagement with cancer participantssurvivors community advisors and partners to refine and optimize methodsprocesses
Ib Identify recruit and consent eligible IA cancer participantssurvivors Ic Implement tissue acquisition epidemiologic behavioral and clinical data collection conduct continuous assessment of performance benchmarks
Id Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select
SECONDARY OBJECTIVE
I Translate any discoveries to improved cancer screening precision prevention and therapeutic intervention that can be used to enhance cancer screening and precision prevention and improve cancer outcomes in Indigenous American participants and communities
OUTLINE
Patients undergo collection of blood or saliva samples on study for genetic testing Patients also undergo collection of leftover tissue obtained from standard of care SOC surgical procedure or biopsy or stored tissue samples for genetic testing on study Patients receive the results of their genetic testing and are given resources for counseling and further care
After completion of study intervention patients are followed up once a year up to 5 years from study registration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None