Journey to Understanding - American Indian Peoples Engagement in Cancer Research Arizona (JUNIPER)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Successful accrual of Indigenous American (IA) participants
Study Overview
Brief Summary
This clinical trial is studying the genetic changes in cells associated with different types of cancer in American Indian (AI) populations in the Southwest to improve cancer screening, precision prevention, and therapeutic intervention for individual in these communities. AI 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, AIs have been understudied and little is known about the molecular characterization of tumors arising in AIs. Undergoing genetic testing of tumors may improve cancer outcomes in AI participants and communities.
Detailed Description
PRIMARY OBJECTIVES:
I. To develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit American Indians (AIs) 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 participants/survivors, community advisors, and partners to refine and optimize methods/processes.
Ib. Identify, recruit, and consent eligible AI cancer participants/survivors. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female adults >= 18 years of age
- •Cancer patient undergoing active treatment or a cancer survivor
- •Self-identify as American Indian
Exclusion Criteria
- •Unable to provide informed consent
- •Individuals who are under 18 years of age
- •Prisoners
Arms & Interventions
Screening (blood, saliva, tissue collection, genetic testing)
Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
Intervention: Communication Intervention (Other)
Screening (blood, saliva, tissue collection, genetic testing)
Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
Intervention: Genetic Testing (Other)
Screening (blood, saliva, tissue collection, genetic testing)
Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
Intervention: Biospecimen Collection (Procedure)
Screening (blood, saliva, tissue collection, genetic testing)
Patients undergo collection of blood or saliva samples on study for genetic testing. Patients also undergo collection of leftover tissue obtained from SOC surgical procedure or biopsy, or stored tissue samples for genetic testing as well as mouthwash saliva samples on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
Intervention: Survey Administration (Other)
Outcomes
Primary Outcomes
Successful accrual of Indigenous American (IA) participants
Time Frame: Up to 5 years
Assessed by the number of IA participants consented to study.
Return of valuable genetic results to participants
Time Frame: Up to 5 years
Assessed by the number of participants who receive genetic results. Clinically useful genomic data will be returned to participants with navigation to counseling and clinical resources as warranted and as they select.
Successful accrual of American Indian (AI) participants
Time Frame: Up to 5 years
Assessed by the number of AI participants consented to study.
Secondary Outcomes
No secondary outcomes reported