Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study
NCT ID: NCT04456140
Last Updated: 2023-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
230 participants
INTERVENTIONAL
2020-06-29
2021-09-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood samples
Genetic Counseling
Watch pre-test genetic counseling video
Genetic Testing
Undergo genetic testing
Survey Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Genetic Counseling
Watch pre-test genetic counseling video
Genetic Testing
Undergo genetic testing
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Niloy Jewel (Jewel) Samadder
Principal Investigator
Principal Investigators
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Niloy J Samadder
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Other Identifiers
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NCI-2020-04429
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-011472
Identifier Type: OTHER
Identifier Source: secondary_id
19-011472
Identifier Type: -
Identifier Source: org_study_id
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