Cancer Genetic Testing in Ethnic Populations

NCT04475640 | Recruiting

• 2 other identifiers: GEMINI19-006717
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 2

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.

Conditions

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; Skin Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

Screening (biospecimen collection)

EXPERIMENTAL

Patients undergo collection of blood or saliva sample for genetic testing.

Procedure: Biospecimen Collection; Other: Genetic Testing

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood sample

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Screening (biospecimen collection)

Genetic Testing OTHER

Undergo genetic testing

Also known as: Genetic Analysis, Genetic Examination, Genetic Test

Screening (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms, Unknown Primary; Brain Neoplasms

Interventions

Specimen Handling; Genetic Testing

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Jewel Samadder, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 17, 2020
• Study Start: January 13, 2020
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): October 15, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

US (2)