Family Communications After Genetic Testing for Colorectal Cancer

This study is looking at the best way to share genetic testing results with family members of people newly diagnosed with colorectal cancer. About 30% of colorectal cancers have a genetic cause, and many people with these genetic changes don't know they are at higher risk. This trial compares two ways of sharing this information: either the patient (called the "proband") shares the information with their first-degree relatives (parents, siblings, children), or a healthcare provider does. The goal is to see which method leads to more relatives getting genetic testing themselves. You can join if you are 18 or older and have been recently diagnosed with stage I to IV colorectal adenocarcinoma.

Study design: This interventional study plans to enroll 4186 participants. It compares two methods of communication to see which is more effective.
What's involved: Participants will undergo blood sample collection and genetic testing. They will also be part of a communication intervention and complete surveys.
Compensation: Not stated in the trial record.
Follow-up: The study measures how many relatives get genetic testing within 6 months of the patient joining the study, and disease prevention efforts at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Family Communications After Genetic Testing

Recruiting

NAAges 18+InterventionalScreening

Alliance for Clinical Trials in Oncology

~4,186 participants

Updated 2026-09-02 on ClinicalTrials.gov

What's tested:Biospecimen CollectionGenetic TestingCommunication InterventionSurvey Administration

At a glance

Recruiting sites

317 of 319 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Proportion of eligible first-degree relatives (FDRs) of the affected proband who underwent genetic testing

Measured over Within 6 months of proband randomization

Conditions

Colon Adenocarcinoma

Colorectal Adenocarcinoma

Rectal Adenocarcinoma

Stage I Colon Cancer AJCC v8

Stage I Colorectal Cancer AJCC v8

Stage I Rectal Cancer AJCC v8

Stage II Colon Cancer AJCC v8

Stage II Colorectal Cancer AJCC v8

Stage II Rectal Cancer AJCC v8

Stage III Colon Cancer AJCC v8

Stage III Colorectal Cancer AJCC v8

Stage III Rectal Cancer AJCC v8

Stage IV Colon Cancer AJCC v8

Stage IV Colorectal Cancer AJCC v8

Stage IV Rectal Cancer AJCC v8

NCT07143487

Where you'd take part

This study runs at 319 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Abbott-Northwestern Hospital
Minneapolis, Minnesotastudy coordinator listed
Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaskastudy coordinator listed
Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaskastudy coordinator listed
Recruiting
Alaska Women's Cancer Care
Anchorage, Alaskastudy coordinator listed
Recruiting
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraskastudy coordinator listed
Recruiting
Alegent Health Immanuel Medical Center
Omaha, Nebraskastudy coordinator listed
Recruiting
Alegent Health Lakeside Hospital
Omaha, Nebraskastudy coordinator listed
Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaskastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Frank A Sinicrope · STUDY_CHAIR · Alliance for Clinical Trials in Oncology

Who to contact

Rachel Wills

[email protected]

773-702-9814

Email the study team

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Eligibility criteria

Inclusion

STEP 1 PROBANDS: Age \>= 18 years

STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV

Histologically proven stage I to IV colon or rectal adenocarcinoma (any T or N, M+). Tumors deemed to originate in the colon can extend into/involve the small bowel (e.g., those at the ileocecal valve). Tumors will be regarded as originating in the colon if the entire tumor is in the colon. In the case of rectal involvement, the cancer will be considered a rectal primary

Patients with more than one primary colon adenocarcinoma are eligible

STEP 1 PROBANDS: No patients with stage 0 or in-situ colorectal cancer

STEP 1 PROBANDS: Patients who have had prior malignancies are eligible, including non-invasive cancers

STEP 1 PROBANDS: Patients with synchronous second malignancies are eligible

STEP 1 PROBANDS: Have not received germline testing in the 2 years prior to enrollment or known hereditary colon cancer syndromes

STEP 1 PROBANDS: Patients must have at least 2 living FDRs who meet the eligibility criteria, with whom the patient is willing to share their cancer diagnosis

STEP 1 PROBANDS: In order to complete the mandatory patient-completed measures and view the video and receive genetic education and counseling, participants must be able to speak and read English or Spanish

STEP 1 PROBANDS: No known diagnosis of dementia or cognitive impairment. Persons with impaired decision-making capacity are ineligible as they need to be able to understand genetic test results, its implications for the patient and family, and explain genetic test results to their family members

STEP 2 PROBANDS: Probands positive for a pathogenic germline variant (PGV) in a cancer susceptibility gene

FDRs: Age \>= 18 years

FDRs: Have not previously received germline genetic testing or known hereditary colon cancer syndromes

FDRs: FDRs must reside within the United States, as genetic testing from LabCorp is only available to United States (U.S.) residents

FDRs: In order to complete the mandatory patient-completed measures, participants must be able to speak and read English or Spanish

What this trial measures

Proportion of eligible first-degree relatives (FDRs) of the affected proband who underwent genetic testingWithin 6 months of proband randomization
This is a binary outcome. To test for a between-arm difference in the proportion of eligible FDRs receiving genetic testing, the primary analysis will apply a mixed-effects logistic regression model to account for between-family variability or equivalently the within family correlation. The mixed-effects logistic regression model will be applied separately within the subset of families who are associated with a proband who has Lynch syndrome (LS), and within the subset of families who are associated with a proband who harbors non-LS pathogenic germline variants (PGVs).

Trialytics