Trial Outcomes & Findings for Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial (NCT NCT03765736)

Last Updated: 2025-08-29

Results Overview

This is defined as a patient who received a trial recommendation per the COLOMATE companion trial recommendation form. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).

Recruitment status

TERMINATED

Target enrollment

199 participants

Primary outcome timeframe

6 months

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Screening (Genetic Testing) Patients submit blood samples for genetic testing. Genetic Testing: Undergo genetic testing
Overall Study STARTED	197
Overall Study COMPLETED	197
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Screening (Genetic Testing) n=197 Participants Patients submit blood samples for genetic testing. Genetic Testing: Undergo genetic testing
Age, Continuous	57.4 years STANDARD_DEVIATION 11.78 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	174 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants
Race (NIH/OMB) White	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants
Region of Enrollment United States	197 participants n=5 Participants
Primary Tumor Site Left	146 Participants n=5 Participants
Primary Tumor Site Multiple/Other	11 Participants n=5 Participants
Primary Tumor Site Right	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All eligible patients whose genomic profile was available for COLOMATE steering committee review are included in analysis

Outcome measures

Outcome measures
Measure	Screening (Genetic Testing) n=191 Participants Patients submit blood samples for genetic testing. Genetic Testing: Undergo genetic testing
The Proportion of Patients Who Have an Actionable Genomic Profile	37.17 percent of participants Interval 30.32 to 44.03

PRIMARY outcome

Timeframe: 3.5 years

Population: All eligible patients who had an actionable genomic profile were included in analysis

This is defined as a patient who has an actionable genomic profile that enrolls in their recommended companion trial. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).

Outcome measures

Outcome measures
Measure	Screening (Genetic Testing) n=71 Participants Patients submit blood samples for genetic testing. Genetic Testing: Undergo genetic testing
Companion Trial Enrollment	26.76 percent of participants Interval 16.46 to 37.06

Adverse Events

Screening (Genetic Testing)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Strickler, MD

Duke Cancer Institute

Phone: (919) 668-6608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place