Spots Global Cancer Trial Database for Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study

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Trial Identification

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

Official Title: Clinical Validation of the ColonoSight Test: a Multi-target Stool RNA (Mt-sRNA) Assay for Colorectal Neoplasia Screening in Average-risk Individuals Aged >45 Years Old

Study ID: NCT04739722

Conditions

Colorectal Cancer

Advanced Adenocarcinoma

Adenoma Colon

Polyp of Colon

Interventions

Colosense Stool Sample Collection Kit

Study Description

Brief Summary: This study will be a prospective analysis conducted by Geneoscopy Inc. to evaluate the Colosense test, which is a multi-target stool RNA test for colorectal screening.

Detailed Description: Patients who are eligible for a colonoscopy (i.e., average risk individuals 45 years of age and older who are not up-to-date with screening guidelines) will be enrolled in the study. Stool samples returned to Geneoscopy's Laboratories by the participant will be subjected to the Colosense test system, and a result will be generated. The result will be compared to an optical colonoscopy to determine: 1) sensitivity for colorectal cancer, advanced adenomas, and other precancerous adenomas and 2) specificity for hyperplastic polyps and no findings on a colonoscopy. This study will be used for the clinical validation of the Colosense test.