Health TrialsbyHealthPanel

Family Communications After Genetic Testing

ConditionsColon AdenocarcinomaColorectal AdenocarcinomaRectal AdenocarcinomaStage I Colon Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage I Rectal Cancer AJCC v8Stage II Colon Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Rectal Cancer AJCC v8Stage III Colon Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IV Colon Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlliance for Clinical Trials in Oncology

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Genetic Testing

    Other intervention

    Undergo genetic testing

  • Communication Intervention

    Other intervention

    Receive proband-mediated communication

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

4,186 Participants
are divided into 3 treatment groups
Group A: Step 1 (biospecimen collection, genetic testing)Experimental treatment 2 interventions
Group B: Step 2, Arm A (proband-mediated)Active comparator 2 interventions
Group C: Step 2, Arm B (provider-mediated)Experimental treatment 2 interventions

Trial outcomes

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).

Time frame
Within 6 months of proband randomization

Secondary outcomes

1

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

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now