- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04475640
Cancer Genetic Testing in Ethnic Populations
GEMINI - Cancer Genetic Testing in Ethnic Populations
Study Overview
Status
Conditions
- Malignant Solid Neoplasm
- Breast Carcinoma
- Digestive System Carcinoma
- Head and Neck Carcinoma
- Skin Carcinoma
- Malignant Female Reproductive System Neoplasm
- Malignant Brain Neoplasm
- Carcinoma of Unknown Primary
- Central Nervous System Carcinoma
- Genitourinary System Carcinoma
- Malignant Musculoskeletal Neoplasm
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Recruiting
- Mayo Clinic in Arizona
-
Principal Investigator:
- Niloy J. Samadder, M.D.
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Recruiting
- Mayo Clinic in Florida
-
Principal Investigator:
- Jeremy C. Jones, M.D.
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Screening (biospecimen collection)
Patients undergo collection of blood or saliva sample for genetic testing.
|
Undergo genetic testing
Other Names:
Undergo collection of blood sample
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of pathogenic germline mutations in enrolled patients within each cancer site
Time Frame: 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.
|
Study completion (2 years)
|
Prevalence of positive pathogenic germline mutations
Time Frame: 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.
|
Study completion (2 years)
|
Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria
Time Frame: 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.
|
Study completion (2 years)
|
Impact of germline genetic testing on both therapeutic management and targeted cancer prevention
Time Frame: 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.
|
Study completion (2 years)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Niloy J. Samadder, M.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Skin Diseases
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Neoplasms
- Breast Neoplasms
- Carcinoma
- Brain Neoplasms
- Genital Neoplasms, Female
Other Study ID Numbers
- 19-006717 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2020-04427 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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