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Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456140
Recruitment Status : Active, not recruiting
First Posted : July 2, 2020
Last Update Posted : March 4, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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Brief Summary:
This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent's Riverside. This may help doctors better understand and/or treat others who have genetic mutations.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Digestive System Neoplasm Malignant Brain Neoplasm Malignant Central Nervous System Neoplasm Malignant Female Reproductive System Neoplasm Malignant Genitourinary System Neoplasm Malignant Head and Neck Neoplasm Malignant Musculoskeletal Neoplasm Malignant Solid Neoplasm Metastatic Malignant Neoplasm of Unknown Primary Skin Carcinoma Procedure: Biospecimen Collection Other: Genetic Counseling Other: Genetic Testing Other: Survey Administration Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To determine the prevalence of genetic mutations in cancer patients seeking care at the Mayo Clinic Cancer Center at St. Vincent's Riverside in Jacksonville, Florida.

SECONDARY OBJECTIVES:

I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:

Ia. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network [NCCN]) based approach for genetic evaluation.

Ib. Determine the percentage of relatives of mutation positive probands undergoing family variant testing within a 3 month window of return of testing results.

Ic. Assess patient experience and barriers to care with a genetic service line via survey measures.

Id. Develop a biorepository of samples (blood) from cancer patients participating in this protocol.

OUTLINE:

Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent's Mayo Clinic Embedded Cancer Center
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : July 15, 2024
Estimated Study Completion Date : July 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arms and Interventions
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Arm Intervention/treatment
Experimental: Prevention (pre-genetic test counseling, genetic testing)
Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.
 Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Genetic Counseling
Watch pre-test genetic counseling video

Other: Genetic Testing
Undergo genetic testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test

Other: Survey Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of pathogenic germline mutations [ Time Frame: Up to 3 months ]
    Will be assessed by each cancer site, age (< 60 years old versus [vs.] >= 60 years old), and stage (early vs. advanced) via descriptive statistics.

  2. Difference between prevalence of positive pathogenic germline mutations [ Time Frame: Up to 3 months ]
    Will be assessed by 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.

  3. Rate of mutation detection [ Time Frame: Up to 3 months ]
    Will be compared 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.

  4. Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families [ Time Frame: Up to 3 months ]
    Assessed using logistic regression

  5. Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families [ Time Frame: Up to 3 months ]
    Assessed using pairwise post-hoc analyses


Secondary Outcome Measures :
  1. Differences in survey responses between patient groups [ Time Frame: Up to 3 months ]
    Patients will be grouped by genetic test result (positive vs. negative), age (< 60 years old vs. >= 60 years old), stage (early vs. advanced), and over time (enrollment vs. after test results are received).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals diagnosed with any solid tumor cancer (stages 1-4) including, but not limited to, gastrointestinal, breast, gynecological, genitourinary, skin, central nervous system (CNS)/brain, head/neck, musculoskeletal or cancer of unknown primary
  • 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:

  • Individuals who do not meet study inclusion criteria
  • Individuals with an active hematologic malignancy
  • Patients who have had prior germline genetic testing involving a 40+ gene panel within the last 24 months at Mayo Clinic or St Vincent's Healthcare and available for review by the research coordinator at time of consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456140


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Niloy J Samadder Mayo Clinic
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04456140    
Other Study ID Numbers: 19-011472
NCI-2020-04429 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-011472 ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Breast Neoplasms
Head and Neck Neoplasms
Brain Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Genital Neoplasms, Female
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms by Site
Breast Diseases
Skin Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Digestive System Diseases
Gastrointestinal Diseases
Urogenital Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes