Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent's Mayo Clinic Embedded Cancer Center
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Carcinoma
- Sponsor
- Mayo Clinic
- Enrollment
- 230
- Locations
- 2
- Primary Endpoint
- Rate of mutation detection
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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. Ib. Determine the percentage of relatives of mutation positive probands undergoing family variant testing within a 3 month window of return of testing results. Ic. Assess patient experience and barriers to care with a genetic service line via survey measures. Id. Develop a biorepository of samples (blood) from cancer patients participating in this protocol. OUTLINE: Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.
Investigators
Niloy Jewel (Jewel) Samadder
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Rate of mutation detection
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Up to 3 months
Assessed using pairwise post-hoc analyses
Secondary Outcomes
- Differences in survey responses between patient groups(Up to 3 months)