Cancer Genetic Testing in Ethnic Populations

Mayo Clinic1,800 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

1,800

Conditions

Breast Carcinoma Carcinoma of Unknown Primary

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Study completion (2 years)

Cancer Genetic Testing in Ethnic Populations

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Central Contacts