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

Inherit - A Trial of Pro-Active Genetic Testing in Cancer Patients at St. Vincent's Mayo Clinic Embedded Cancer Center

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.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm; Breast Carcinoma; Digestive System Neoplasm; Skin Carcinoma; Malignant Female Reproductive System Neoplasm; Metastatic Malignant Neoplasm of Unknown Primary; Malignant Head and Neck Neoplasm; Malignant Brain Neoplasm; Malignant Central Nervous System Neoplasm; Malignant Musculoskeletal Neoplasm; Malignant Genitourinary System Neoplasm
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Other: Genetic Testing; Other: Genetic Counseling

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 Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Survey Administration; Ancillary studies; Other: Genetic Testing; Undergo genetic testing; Other Names: genetic analysis; Genetic Examination; Genetic Test; Other: Genetic Counseling; Watch pre-test genetic counseling video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of pathogenic germline mutations	Will be assessed by each cancer site, age (< 60 years old versus [vs.] >= 60 years old), and stage (early vs. advanced) via descriptive statistics.	Up to 3 months
Difference between prevalence of positive pathogenic germline mutations	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.	Up to 3 months
Rate of mutation detection	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.	Up to 3 months
Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families	Assessed using logistic regression	Up to 3 months
Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families	Assessed using pairwise post-hoc analyses	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in survey responses between patient groups	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).	Up to 3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Niloy J Samadder, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2020
• Primary Completion (Actual): September 21, 2021
• Study Completion (Actual): September 21, 2021

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Breast Diseases; Neoplastic Processes; Neoplasm Metastasis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma; Brain Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Genital Neoplasms, Female; Neoplasms, Unknown Primary
• Other Study ID Numbers: 19-011472 (Other Identifier: Mayo Clinic in Arizona); NCI-2020-04429 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No