Status:
NOT_YET_RECRUITING
Family Communications After Genetic Testing
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colon Adenocarcinoma
Colorectal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 colore...
Detailed Description
PRIMARY OBJECTIVES: I. To compare the proportion of first-degree relatives (FDRs) of probands with Lynch Syndrome who undergo germline testing in the provider-mediated arm (Arm B) versus the proband-...
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
- \* 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
- \-
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 5 2032
Estimated Enrollment :
4186 Patients enrolled
Trial Details
Trial ID
NCT07143487
Start Date
November 5 2025
End Date
November 5 2032
Last Update
September 16 2025
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