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

NCT04456140 | Completed Phase 1

• 2 other identifiers: 19-011472NCI-2020-04429
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Differences in survey responses between patient groups

  Up to 3 months

Study Arms (1)

Prevention (pre-genetic test counseling, genetic testing)

EXPERIMENTAL

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; Other: Genetic Counseling; Other: Genetic Testing; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Prevention (pre-genetic test counseling, genetic testing)

Genetic Counseling OTHER

Watch pre-test genetic counseling video

Prevention (pre-genetic test counseling, genetic testing)

Genetic Testing OTHER

Undergo genetic testing

Also known as: genetic analysis, Genetic Examination, Genetic Test

Prevention (pre-genetic test counseling, genetic testing)

Survey Administration OTHER

Ancillary studies

Prevention (pre-genetic test counseling, genetic testing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Digestive System Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Urogenital Neoplasms; Head and Neck Neoplasms; Neoplasms, Unknown Primary

Interventions

Genetic Counseling; Genetic Testing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Genetic Services; Health Services; Health Care Facilities Workforce and Services; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Diagnostic Services; Preventive Health Services

Study Officials

• Niloy J Samadder

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 2, 2020
• Study Start: June 29, 2020
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

US (2)