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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04456140.
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.
Lead OrganizationMayo Clinic in Florida
Principal InvestigatorNiloy Jewel Samadder
