GEMINI - Cancer Genetic Testing in Ethnic Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 1,800
- 试验地点
- 4
- 主要终点
- Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria
研究概览
简要总结
This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.
详细描述
PRIMARY OBJECTIVE:
I. To determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic Arizona and Mayo Clinic Florida cancer clinics.
SECONDARY OBJECTIVES:
I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:
Ia. Determine prevalence of pathogenic germline mutation detected by multi-gene panel testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years of age
- •Individuals diagnosed with any solid tumor cancer including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary; and presenting to Mayo Clinic (MC Arizona or MC Florida) for clinical management/treatment; and patients receive genetic testing as described above
- •Self-identified as being from various ethnic populations including Hispanic/Latino, Native American/Alaskan, African American (including of African descent), Asian and other European populations
- •Blood collection is feasible (health, access and/or tolerability) for requested blood sample(s)
- •Individuals have agreed to participate and signed the study informed consent form
排除标准
- •Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic and available for review by the research coordinator at time of consent
- •Past or current history of hematological cancer (including leukemias, multiple myeloma)
- •All bone marrow transplants
结局指标
主要结局
Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria
时间窗: Study completion (2 years)
Will compare the rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria within cancer site, age, and stage using logistic regression and pairwise post-hoc analyses as needed.
Prevalence of pathogenic germline mutations in enrolled patients within each cancer site
时间窗: Study completion (2 years)
Will identify the prevalence of pathogenic germline mutations in enrolled patients within each cancer site, age (\< 60 years old versus (vs.) \>= 60 years old), and stage (early vs. advanced) via descriptive statistics.
Prevalence of positive pathogenic germline mutations
时间窗: Study completion (2 years)
Will determine whether the prevalence of positive pathogenic germline mutations differs between cancer sites, age of diagnosis, and stage of diagnosis using logistic regression analysis across all cancer site groups and pairwise post-hoc analyses using Tukey's correction for multiple comparisons across pairs of cancer sites and chi-square tests of differences between age and stage groups.
Impact of germline genetic testing on both therapeutic management and targeted cancer prevention
时间窗: Study completion (2 years)
Will assess the impact of germline genetic testing on both therapeutic management and targeted cancer prevention in family members using logistic regression and pairwise post-hoc analyses as needed.
次要结局
未报告次要终点