NCT04456140

Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study

Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent's Mayo Clinic Embedded Cancer Center

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma
• Digestive System Neoplasm
• Malignant Brain Neoplasm
• Malignant Central Nervous System Neoplasm
• Malignant Female Reproductive System Neoplasm
• Malignant Genitourinary System Neoplasm
• Malignant Head and Neck Neoplasm
• Malignant Musculoskeletal Neoplasm
• Malignant Solid Neoplasm
• Metastatic Malignant Neoplasm of Unknown Primary
• Skin Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Genetic Counseling	Watch pre-test genetic counseling video
OTHER	Genetic Testing	Undergo genetic testing
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2020-06-29
• Primary completion: 2021-09-21
• Completion: 2021-09-21
• First posted: 2020-07-02
• Last updated: 2023-07-24

Locations

2 sites across 1 country: United States