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Cancer Genetic Testing in Ethnic Populations

Primary Purpose

Breast Carcinoma, Carcinoma of Unknown Primary, Central Nervous System Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Genetic Testing
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in ArizonaRecruiting
  • Mayo Clinic in FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (biospecimen collection)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2020
Last Updated
October 5, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04475640
Brief Title
Cancer Genetic Testing in Ethnic Populations
Official Title
GEMINI - Cancer Genetic Testing in Ethnic Populations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
October 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening (biospecimen collection)
Arm Type
Experimental
Arm Description
Patients undergo collection of blood or saliva sample for genetic testing.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo collection of blood sample
Intervention Type
Other
Intervention Name(s)
Genetic Testing
Other Intervention Name(s)
genetic analysis, Genetic Examination, Genetic Test
Intervention Description
Undergo genetic testing
Primary Outcome Measure Information:
Title
Prevalence of pathogenic germline mutations in enrolled patients within each cancer site
Description
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)
Title
Prevalence of positive pathogenic germline mutations
Description
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)
Title
Rate of mutation detection via genetic testing to clinical practice guidelines of traditional family history criteria
Description
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)
Title
Impact of germline genetic testing on both therapeutic management and targeted cancer prevention
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niloy J Samadder
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Niloy J. Samadder, M.D.
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Jeremy C. Jones, M.D.

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Cancer Genetic Testing in Ethnic Populations

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