An interventional study of Biospecimen Collection and Genetic Testing in Colon Adenocarcinoma, Colorectal Adenocarcinoma and Rectal Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology. Recruiting at 365 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Alliance for Clinical Trials in Oncology · Not applicable, Interventional, and Screening
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.
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-mediated (Arm A) at 6 months.
II. To compare the proportion of FDRs of proband with a non-Lynch pathogenic germline variant who undergo germline testing in the provider-mediated arm (Arm B) versus the proband-mediated arm (Arm A) at 6 months.
SECONDARY OBJECTIVE:
I. To compare the proportion of FDRs with a pathogenic germline variant (PGV) who underwent disease prevention efforts at 12 months between the provider-mediated arm (Arm B) and the proband-mediated cascade testing arm (Arm A).
EXPLORATORY OBJECTIVES:
I. To assess differences in percentages of cascade genetic testing within the following proband subgroups: race/ethnicity (non-Hispanic whites; other race/ethnicities), sex (females; males), age (>= 50; \< 50), tumor location (colon; rectal), tumor stage (stage I-II; stage III-IV), geographic location (urban; rural), and receipt of medical care in an academic versus (vs.) community setting.
III. To determine the prevalence and spectrum of pathogenic germline variants in cancer susceptibility genes by analysis of results of upfront germline testing in a multi-site cancer cooperative group study population with newly diagnosed CRC.
IV. Assess the pattern of accrual of demographic patient subgroups including racial/ethnic minority and rural individuals at the initial 50% of accrual enrolled and at the end of the trial.
V. To compare disease-free survival (DFS) of the proband at 3 years between the direct-contact arm (Arm B) and the proband-directed cascade testing arm (Arm A).
V. To evaluate the completion rate of a Social Determinants of Health questionnaire with patient directed questions .
OUTLINE:
STEP 1: Patients (probands) undergo collection of blood samples and genetic testing on study.
STEP 2: Probands with pathogenic or likely pathogenic germline variants and their FDRs are randomized to 1 of 2 arms.
ARM A: FDRs receive proband-mediated communication about the proband's genetic testing results.
ARM B: FDRs receive provider-mediated communication about the proband's genetic testing results.
Probands are followed for up to 3 years and FDRs are followed for up to 1 year
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 4,186 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
STEP 1 PROBANDS: Patients with a newly diagnosed (within 3 months of registration), primary colorectal adenocarcinoma, stage I to IV
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
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Probands undergo collection of blood samples and genetic testing on study.
Procedure: Biospecimen Collection · Other: Genetic Testing
FDRs receive proband-mediated communication about the proband's genetic testing results.
Other: Communication Intervention · Other: Survey Administration
FDRs receive provider-mediated communication about the proband's genetic testing results.
Other: Communication Intervention · Other: Survey Administration
Undergo collection of blood samples
Undergo genetic testing
Receive proband-mediated communication
Ancillary studies
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).
Time frame: Within 6 months of proband randomization
Proportion of eligible FDRs with a PGV undergoing disease prevention efforts
Binary outcome indicating whether an eligible FDR with a PGV who underwent disease prevention efforts at 12 months between the provider-mediated arm (Arm B) and the proband-mediated cascade testing arm (Arm A).
Time frame: Within 12 months of proband randomization
Proportion of eligible FDRs of the affected proband who underwent genetic testing
Will repeat LS and non-LS analyses according to pre-defined proband sub-groups (Non-Hispanic White vs. other races/ethnicities; female vs. male; age \>= 50 vs. \< 50; urban vs. rural; academic setting vs. community setting). It is clinically important to quantify the effect of the provider-mediated direct-contact approach within these subgroups and the degree of imprecision as measured by the corresponding confidence interval. Thus, we will report the odds ratio and descriptive 95% confidence interval.
Time frame: Within 6 months of proband randomization
Degree to which the somatic tumor profiling identifies a germline event
Will estimate the proportion of cases where the germline mutation is detected by somatic next generation sequencing testing of the tumor. The corresponding lower bound of the one-sided 90% interval will be calculated for the true but unknown proportion.
Time frame: up to 3 years
Spectrum and prevalence of PGVs in cancer susceptibility genes
For each, descriptive statistics will include the frequency and percentage as well as the standard error.
Time frame: Up to 3 years
Disease-free survival (DFS) of probands
: DFS will be compared between direct-contact arm and proband-directed cascade testing arm. DFS percentages, standard errors, and the intervention effect comparison will be obtained from the Kaplan-Meier method, Greenwood's formula, and log-rank tests, respectively. Cox proportional hazards regression models will be used to estimate relative risks and 95% confidence intervals for the intervention comparison.
Time frame: From the date the patient is randomized on study for first documentation of primary tumor recurrence/relapse or death, assessed up to 3 years
Accrual patterns
Summary of participant accrual over time, including recruitment rates by site and arm.
Time frame: up to 3 years
Showing the first 100 of 365 sites across 2 countries. Choose a country and city above to see the rest.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Nov 2029, 42 months after the start.
Of 382 non-industry interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 55. This study's planned 42 months is above that.
Counting every sponsor, half of 404 studies reached it within 30 months; a quarter within 16 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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