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

NCT04739722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14263

Last updated 2024-10-01

Study results available
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Summary

This study was a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColoSense test, which is a multi-target stool RNA test for colorectal cancer screening.

Conditions

Interventions

DIAGNOSTIC_TEST

ColoSense

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average-risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Sponsors & Collaborators

  • Geneoscopy, Inc.

    lead INDUSTRY

Principal Investigators

  • Faith Holmes, MD · Elligo Health Research

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2022-10-27
Completion
2024-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04739722 on ClinicalTrials.gov