Cancer Genetic Testing in Ethnic Populations

Breast Carcinoma Clinical Trial

Official title:

GEMINI - Cancer Genetic Testing in Ethnic Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475640
• Other study ID #: 19-006717
• Secondary ID: NCI-2020-0442719
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: October 15, 2024

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood sample

Other:
• Genetic Testing
Undergo genetic testing

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

•   Mayo Clinic Clinical Trials