Trial Outcomes & Findings for Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study (NCT NCT04739722)

NCT ID: NCT04739722

Last Updated: 2024-10-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14263 participants
• Primary outcome timeframe: 120 days from stool sample collection
• Results posted on: 2024-10-01

Participant Flow

Participants were engaged using an online social media platform through a decentralized recruitment effort. Interested participants completed a self-reported online survey to screen for the intended use population and to obtain socioeconomic and demographic information. Enrolled participants provided both written and oral informed consent to complete study requirements and provide medical records.

Of the 14,263 subjects enrolled in the CRC-PREVENT study, 8,920 completed all study requirements and 7,763 subjects were considered average-risk.

Participant milestones

Measure	Enrolled Subjects Enrolled subjects were men and women, 45 years of age or older, inclusive.
Overall Study STARTED	14263
Overall Study COMPLETED	7763
Overall Study NOT COMPLETED	6500

Reasons for withdrawal

Measure	Enrolled Subjects Enrolled subjects were men and women, 45 years of age or older, inclusive.
Overall Study Lost to Follow-up	5301
Overall Study Withdrawal by Subject	42
Overall Study Non Average-risk	1157

Baseline Characteristics

Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study

Baseline characteristics by cohort

Measure	Average Risk Subjects n=7763 Participants Average risk subjects were required to submit a ColoSense test prior to completing a colonoscopy. Subjects were considered eligible for the primary analysis if they were 45 years or older, male or female, met eligibility criteria, and did not report a first degree relative with colorectal cancer.
Age, Continuous	55.3 years n=5 Participants
Sex/Gender, Customized Female	4643 Participants n=5 Participants
Sex/Gender, Customized Male	3111 Participants n=5 Participants
Sex/Gender, Customized Other	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	500 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7121 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	142 Participants n=5 Participants
Race/Ethnicity, Customized American Indian / Alaskan Native	64 Participants n=5 Participants
Race/Ethnicity, Customized Asian	307 Participants n=5 Participants
Race/Ethnicity, Customized Black / African American	821 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian / Other Pacific Islander	17 Participants n=5 Participants
Race/Ethnicity, Customized White	6268 Participants n=5 Participants
Race/Ethnicity, Customized Other	286 Participants n=5 Participants
Region of Enrollment United States	7763 participants n=5 Participants

PRIMARY outcome

Timeframe: 120 days from stool sample collection

Outcome measures

Measure	Colorectal Cancer Subjects (Average Risk) n=27 Participants Subjects in the average risk cohort who had a diagnosis of CRC via colonoscopy.
ColoSense Sensitivity for Colorectal Cancer (CRC) Positive	25 Participants
ColoSense Sensitivity for Colorectal Cancer (CRC) Negative	2 Participants

PRIMARY outcome

Timeframe: 120 days from stool sample collection

Outcome measures

Measure	Colorectal Cancer Subjects (Average Risk) n=514 Participants Subjects in the average risk cohort who had a diagnosis of CRC via colonoscopy.
ColoSense Sensitivity for Advanced Adenoma (AA) Positive	231 Participants
ColoSense Sensitivity for Advanced Adenoma (AA) Negative	283 Participants

PRIMARY outcome

Timeframe: 120 days from stool sample collection

Outcome measures

Measure	Colorectal Cancer Subjects (Average Risk) n=98 Participants Subjects in the average risk cohort who had a diagnosis of CRC via colonoscopy.
ColoSense Sensitivity for Serrated Precancerous Lesions (SPL) Positive	22 Participants
ColoSense Sensitivity for Serrated Precancerous Lesions (SPL) Negative	76 Participants

PRIMARY outcome

Timeframe: 120 days from stool sample collection

Outcome measures

Measure	Colorectal Cancer Subjects (Average Risk) n=7124 Participants Subjects in the average risk cohort who had a diagnosis of CRC via colonoscopy.
ColoSense Specificity for Negative Findings Positive	1027 Participants
ColoSense Specificity for Negative Findings Negative	6097 Participants

Adverse Events

Enrolled Subjects

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enrolled Subjects n=14263 participants at risk Enrolled subjects were men and women, 45 years of age or older, inclusive.
Product Issues Non-serious, Anticipated, Adverse Event	0.01% 1/14263 • Number of events 1 • Adverse event data was collected throughout the duration of the clinical trial (From baseline to study completion, up to 120 days). Only device related adverse events were collected.

Additional Information

Chief Medical and Science Officer

Geneoscopy Inc.

Phone: 314-887-7777

Email: contact@geneoscopy.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place