Brief Summary

This clinical trial compares patient (proband)-mediated communication to provider-mediated communication for improving genetic testing in first-degree relatives of patients with newly diagnosed colorectal cancer. It is estimated that 30% of cases of colorectal cancer have a genetic basis and about 15% of these patients have a disease-causing (pathogenic) inherited (germline) variant in a cancer susceptibility gene. Most individuals carrying a pathogenic germline variant are unaware of their cancer risk and may not meet guidelines for genetic testing. Identifying pathogenic germline variants or hereditary cancer syndromes in cancer patients has important implications for their at-risk relatives who may not know that they are at high risk for cancer. The burden of communicating this risk to first-degree relatives often falls on the patients, who may lack sufficient knowledge to correctly share and explain their genetic test results. Receiving provider-mediated communication of genetic testing results may be more effective at communicating genetic risk to first-degree relatives than the usual practice of proband-mediated communication.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,186

participants targeted

Target at P75+ for not_applicable

Timeline

76mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach

1 country

276 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.6 years study duration

Study Progress5%

Apr 2026Nov 2032

First Submitted

Initial submission to the registry

August 20, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed

7 months until next milestone

Study Start

First participant enrolled

April 6, 2026

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2029

Expected

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2032

Last Updated

July 2, 2026

Status Verified

July 1, 2026

Enrollment Period

3.6 years

First QC Date

August 20, 2025

Last Update Submit

July 1, 2026

Conditions

Colon Adenocarcinoma Rectal Adenocarcinoma Colorectal 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

Outcome Measures

Primary Outcomes (1)

Proportion of eligible first-degree relatives (FDRs) of the affected proband who underwent genetic testing
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).
Within 6 months of proband randomization

Secondary Outcomes (1)

Proportion of eligible FDRs with a PGV undergoing disease prevention efforts
Within 12 months of proband randomization

Other Outcomes (5)

Proportion of eligible FDRs of the affected proband who underwent genetic testing
Within 6 months of proband randomization
Degree to which the somatic tumor profiling identifies a germline event
up to 3 years
Spectrum and prevalence of PGVs in cancer susceptibility genes
Up to 3 years
+2 more other outcomes

Study Arms (3)

Step 1 (biospecimen collection, genetic testing)

EXPERIMENTAL

Probands undergo collection of blood samples and genetic testing on study.

Procedure: Biospecimen CollectionOther: Genetic Testing

Step 2, Arm A (proband-mediated)

ACTIVE COMPARATOR

FDRs receive proband-mediated communication about the proband's genetic testing results.

Other: Communication InterventionOther: Survey Administration

Step 2, Arm B (provider-mediated)

EXPERIMENTAL

FDRs receive provider-mediated communication about the proband's genetic testing results.

Other: Communication InterventionOther: Survey Administration

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Step 1 (biospecimen collection, genetic testing)

Communication InterventionOTHER

Receive proband-mediated communication

Step 2, Arm A (proband-mediated)Step 2, Arm B (provider-mediated)

Survey AdministrationOTHER

Ancillary studies

Step 2, Arm A (proband-mediated)Step 2, Arm B (provider-mediated)

Genetic TestingOTHER

Undergo genetic testing

Step 1 (biospecimen collection, genetic testing)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
\* No persons with a known psychiatric or documented developmental disorder that affects cognitive or emotional functions to the extent that the capacity for judgment and reason is significantly diminished, such that they cannot participate based on the judgment of the treating physician
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
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (276)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

RECRUITING

Alaska Breast Care and Surgery LLC