Recruiting

Genetic Testing

Sponsor:

City of Hope Medical Center

Code:

NCT05772130

Conditions

Hematopoietic and Lymphoid System Neoplasm

Hereditary Malignant Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Best Practice

Electronic Health Record Review

Personal Contact

Survey Administration

Study Details

Brief summary:

This clinical trial tests whether provider-mediated communication of genetic testing results to at-risk relatives of cancer patients can help improve genetic counseling and testing rates. Approximately 15% of people with cancer have an inherited form of cancer due to changes in a gene that they have inherited from one of their parents. These changes increase a person's risk for developing cancer. Most people who have an inherited harmful change in a cancer risk gene don't know that they have it and are therefore not able to get the health care that they need. The primary reason for this problem has been a lack of genetic counseling and testing for cancer patients and patients with a strong family history of cancer. Another reason for this lack of awareness is that, when cancer runs in a family, the patient who carries the gene change usually has to communicate the genetic risk information to their family members. When this process doesn't work well, family members may not know that they need to get genetic testing and then may not get potentially life-saving care. Provider-mediated contact to discuss genetic test results may help improve rates of genetic testing among at-risk relatives of patients with a family cancer syndrome.

Conditions

Hematopoietic and Lymphoid System Neoplasm

Hereditary Malignant Neoplasm

Malignant Solid Neoplasm

Study ID

NCT05772130

Start date

Feb 14, 2023

Status verified date

Dec, 2025

Completion date

Dec 21, 2026

Anticipated

Primary completion date

Dec 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • PATIENTS: Enrolled in City of Hope (COH) institutional review board (IRB) 07047 or have been seen by COH Genetics for genetic testing
  • PATIENTS: Have an pathogenic/ likely pathogenic germline variant
  • PATIENTS: Fluent in English
  • PATIENTS: Age >= 18 years
  • PATIENTS: Willing to provide contact information for eligible first-degree relatives
  • PATIENTS: >= 2 first-degree relatives that are eligible for genetic testing and reside in the United States of America
  • FIRST-DEGREE RELATIVES: Proband is a COH patient and has consented to this study
  • FIRST-DEGREE RELATIVES: First-degree relative of proband
  • FIRST-DEGREE RELATIVES: Resides within the United States
  • FIRST-DEGREE RELATIVES: Has not undergone genetic testing for the known familial variant
  • FIRST-DEGREE RELATIVES: Are fluent in English
  • FIRST-DEGREE RELATIVES: Age >= 18 years

Exclusion Criteria:

  • PATIENTS: Unable to provide informed consent
  • PATIENTS: =< 2 at-risk first-degree relatives who are eligible for genetic testing and/or reside within the United States
  • PATIENTS: Unwilling to provide contact information for family members
  • FIRST-DEGREE RELATIVES: Unable or unwilling to provide informed consent
  • FIRST-DEGREE RELATIVES: Have undergone genetic testing for the known familial variant
  • FIRST-DEGREE RELATIVES: Resides outside of the United States

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Arm I (usual care)

Patients receive a family letter and their genomic test report to share with at-risk first degree relatives on study.

experimental: Arm II (provider-mediated contact)

Patients receive a family letter and their genomic test report to share with at-risk first degree relatives and relatives also receive provider-mediated contact to discuss genetic results on study.

Interventions

Best Practice

Receive family letter and genomic test report

Electronic Health Record Review

Ancillary studies

Personal Contact

Receive family letter and genomic test report with provider-mediated contact

Survey Administration

Ancillary studies

Primary outcome measure

  • The percentage of uptake of cascade testing among patients' first-degree at-risk relatives [ Time Frame: Up to 9 months after enrollment ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Stacy W. Gray

626-218-8662stagray@coh.org

Principal Investigator:

Stacy W. Gray

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jan 5, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-01-05.