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Completed

NCT Number: NCT04456140

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

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.

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Key information

Conditions

Breast Carcinoma Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Digestive System Diseases Digestive System Neoplasm Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Head and Neck Neoplasms Male Urogenital Diseases 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 Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplasms, Unknown Primary Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Carcinoma Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood samples

Genetic Counseling

Other

Watch pre-test genetic counseling video

Genetic Testing

Other

Undergo genetic testing

Other names: genetic analysis, Genetic Examination, Genetic Test

Survey Administration

Other

Ancillary studies

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2020
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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