NCT07143487 Family Communications After Genetic Testing
| NCT ID | NCT07143487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alliance for Clinical Trials in Oncology |
| Condition | Colon Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,186 participants |
| Start Date | 2026-04-06 |
| Primary Completion | 2029-11-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,186 participants in total. It began in 2026-04-06 with a primary completion date of 2029-11-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: \-
Contact & Investigator
Frank A Sinicrope
STUDY CHAIR
Alliance for Clinical Trials in Oncology
Frequently Asked Questions
Who can join the NCT07143487 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colon Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07143487 currently recruiting?
Yes, NCT07143487 is actively recruiting participants. Contact the research team at rwills@bsd.uchicago.edu for enrollment information.
Where is the NCT07143487 trial being conducted?
This trial is being conducted at Anchorage, United States, Anchorage, United States, Anchorage, United States, Anchorage, United States and 11 additional locations.
Who is sponsoring the NCT07143487 clinical trial?
NCT07143487 is sponsored by Alliance for Clinical Trials in Oncology. The principal investigator is Frank A Sinicrope at Alliance for Clinical Trials in Oncology. The trial plans to enroll 4,186 participants.