Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent's Mayo Clinic Embedded Cancer Center
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 230
- 试验地点
- 4
- 主要终点
- Rate of mutation detection
研究概览
简要总结
This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent's Riverside. This may help doctors better understand and/or treat others who have genetic mutations.
详细描述
PRIMARY OBJECTIVE:
I. To determine the prevalence of genetic mutations in cancer patients seeking care at the Mayo Clinic Cancer Center at St. Vincent's Riverside in Jacksonville, Florida.
SECONDARY OBJECTIVES:
I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:
Ia. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network [NCCN]) based approach for genetic evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Individuals diagnosed with any solid tumor cancer (stages 1-4) including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary
- •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
- •Individuals who do not meet study inclusion criteria
- •Individuals with an active hematologic malignancy
- •Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic or St Vincent's Healthcare and available for review by the research coordinator at time of consent
结局指标
主要结局
Rate of mutation detection
时间窗: Up to 3 months
Will be compared 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.
Difference between prevalence of positive pathogenic germline mutations
时间窗: Up to 3 months
Will be assessed by 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.
Prevalence of pathogenic germline mutations
时间窗: Up to 3 months
Will be assessed by each cancer site, age (\< 60 years old versus \[vs.\] \>= 60 years old), and stage (early vs. advanced) via descriptive statistics.
Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families
时间窗: Up to 3 months
Assessed using logistic regression
次要结局
- Differences in survey responses between patient groups(Up to 3 months)
研究者
Niloy Jewel (Jewel) Samadder
Principal Investigator
Mayo Clinic