Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 1 |
Detailed Description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prevention (pre-genetic test counseling, genetic testing) 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. |
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other: Genetic Counseling
Watch pre-test genetic counseling video
Other: Genetic Testing
Undergo genetic testing
Other Names:
Other: Survey Administration
Ancillary studies
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Outcome Measures
Primary Outcome Measures
- Prevalence of pathogenic germline mutations [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.
- Difference between prevalence of positive pathogenic germline mutations [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.
- Rate of mutation detection [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.
- Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families [Up to 3 months]
Assessed using logistic regression
- Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families [Up to 3 months]
Assessed using pairwise post-hoc analyses
Secondary Outcome Measures
- Differences in survey responses between patient groups [Up to 3 months]
Patients will be grouped by genetic test result (positive vs. negative), age (< 60 years old vs. >= 60 years old), stage (early vs. advanced), and over time (enrollment vs. after test results are received).
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 2 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Niloy J Samadder, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-011472
- NCI-2020-04429
- 19-011472
- P30CA015083