Cancer Genetic Testing in Ethnic Populations

Study Overview
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Brief Summary
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This clinical trial examines the integration of cancer genetic testing in various ethnic populations. Studying individuals and families at risk of cancer may help identify cancer genes and other persons at risk. The information from this study may provide an opportunity for cancer risk stratification and individualized screening in these ethnic populations.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic Arizona and Mayo Clinic Florida cancer clinics. SECONDARY OBJECTIVES: I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care: Ia. Determine prevalence of pathogenic germline mutation detected by multi-gene panel testing. Ib. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network [NCCN]) based approach for genetic evaluation. OUTLINE: Patients undergo collection of blood or saliva sample for genetic testing.

Official Title
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GEMINI - Cancer Genetic Testing in Ethnic Populations

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

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Genetic Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at least 18 years of age Individuals diagnosed with any solid tumor cancer including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary; and presenting to Mayo Clinic (MC Arizona or MC Florida) for clinical management/treatment; and patients receive genetic testing as described above Self-identified as being from various ethnic populations including Hispanic/Latino, Native American/Alaskan, African American (including of African descent), Asian and other European populations 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: Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic and available for review by the research coordinator at time of consent Past or current history of hematological cancer (including leukemias, multiple myeloma) All bone marrow transplants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (biospecimen collection)<br>Patients undergo collection of blood or saliva sample for genetic testing. | Procedure: Biospecimen Collection<br>* Undergo collection of blood sample<br>* Other names: Specimen Collection;Other: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pathogenic germline mutations in enrolled patients within each cancer site | Will identify the prevalence of pathogenic germline mutations in enrolled patients within each cancer site, age (< 60 years old versus (vs.) >= 60 years old), and stage (early vs. advanced) via descriptive statistics. | Study completion (2 years) | 
| Prevalence of positive pathogenic germline mutations | Will determine whether the prevalence of positive pathogenic germline mutations differs between 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. | Study completion (2 years) | 
| Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria | Will compare the rate of mutation detection 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. | Study completion (2 years) | 
| Impact of germline genetic testing on both therapeutic management and targeted cancer prevention | Will assess the impact of germline genetic testing on both therapeutic management and targeted cancer prevention in family members using logistic regression and pairwise post-hoc analyses as needed. | Study completion (2 years) |