Journey to Understanding - Indigenous Peoples Engagement in Cancer Research Arizona (JUNIPER)
概览
- 阶段
- 不适用
- 干预措施
- Genetic Testing
- 疾病 / 适应症
- Hematopoietic and Lymphatic System Neoplasm
- 发起方
- Mayo Clinic
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Successful accrual of Indigenous American (IA) participants
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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 participants/survivors, community advisors, and partners to refine and optimize methods/processes. Ib. Identify, recruit, and consent eligible IA 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. 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.
研究者
入排标准
入选标准
- •Male or female adults \>= 18 years of age
- •Cancer patient undergoing active treatment or a cancer survivor
- •Self-identify as Indigenous American
排除标准
- •Unable to provide informed consent
- •Individuals who are under 18 years of age
- •Prisoners
研究组 & 干预措施
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 on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
干预措施: Genetic Testing
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 on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
干预措施: Biospecimen Collection
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 on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
干预措施: Communication Intervention
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 on study. Patients receive the results of their genetic testing and are given resources for counseling and further care.
干预措施: Survey Administration
结局指标
主要结局
Successful accrual of Indigenous American (IA) participants
时间窗: Up to 5 years
Assessed by the number of IA participants consented to study.
Return of valuable genetic results to participants
时间窗: 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.