Cancer Genetic Testing in Ethnic Populations

Not Applicable

Recruiting

• Conditions: Breast Carcinoma; Malignant Brain Neoplasm; Malignant Musculoskeletal Neoplasm; Carcinoma of Unknown Primary; Genitourinary System Carcinoma; Malignant Female Reproductive System Neoplasm; Malignant Solid Neoplasm; Central Nervous System Carcinoma; Digestive System Carcinoma; Head and Neck Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Genetic Testing

• Registration Number: NCT04475640
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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 Timeline

• Study Start: 2019-12-13
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (biospecimen collection)	Biospecimen Collection	Patients undergo collection of blood or saliva sample for genetic testing.
Screening (biospecimen collection)	Genetic Testing	Patients undergo collection of blood or saliva sample for genetic testing.

Primary Outcome Measures

Name	Time	Method
Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria	Study completion (2 years)	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.
Prevalence of pathogenic germline mutations in enrolled patients within each cancer site	Study completion (2 years)	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.
Prevalence of positive pathogenic germline mutations	Study completion (2 years)	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.
Impact of germline genetic testing on both therapeutic management and targeted cancer prevention	Study completion (2 years)	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.

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States