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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456140
• Other study ID #: 19-011472
• Secondary ID: NCI-2020-0442919
• Status: Completed
• Phase: Phase 1
• Start date: June 29, 2020
• Est. completion date: September 21, 2021

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: September 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Central Nervous System Neoplasms
• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Genital Neoplasms, Female
• Head and Neck Neoplasms
• 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
• Neoplasms
• Neoplasms, Unknown Primary
• Nervous System Neoplasms
• Skin Carcinoma

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Other:
• Genetic Counseling
Watch pre-test genetic counseling video
• Genetic Testing
Undergo genetic testing
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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