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

Study 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.

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

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

Intervention / Treatment
-----------------
* Procedure: Biospecimen Collection
* Other: Genetic Counseling
* Other: Genetic Testing
* Other: Survey Administration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (pre-genetic test counseling, genetic testing)<br>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<br>* Undergo collection of blood samples<br>Other: Genetic Counseling<br>* Watch pre-test genetic counseling video<br>Other: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pathogenic germline mutations | Will be assessed by each cancer site, age (< 60 years old versus [vs.] >= 60 years old), and stage (early vs. advanced) via descriptive statistics. | Up to 3 months | 
| Difference between prevalence of positive pathogenic germline mutations | 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. | Up to 3 months | 
| Rate of mutation detection | 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. | Up to 3 months | 
| Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families | Assessed using logistic regression | Up to 3 months | 
| Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families | Assessed using pairwise post-hoc analyses | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in survey responses between patient groups | 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). | Up to 3 months |