Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Adenocarcinoma

Adenoma

Colonic Polyps

Polyps

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pathological Conditions, Anatomical

Intestinal Polyps

All participants will be evaluated with the Colosense Test system and a colonoscopy.

The Colosense Collection Kit provides information on how to collect a stool swab using a fecal immunochemical test (FIT) and how to collect a stool sample using the Colosense Collection Kit. After a stool sample is produced, patients will swab the stool sample using the FIT tube according to instructions and return the stool sample via mail courier to Geneoscopy's Laboratories. Patients will then be directed to receive a colonoscopy. If a lesion is removed during the colonoscopy, the tissue sample will be sent for histopathology review. The colonoscopy report and the histopathology report will be reported to Geneoscopy. Stool samples returned to Geneoscopy's Laboratories will be subjected to the Colosense test system, which includes targeted nucleic acid enrichment and biomarkers quantification via droplet digital polymerase chain reaction. The FIT returned in the Colosense Collection Kit will also be read by laboratory technologists at Geneoscopy.

Colosense Stool Sample Collection Kit

Elizabeth Wurtzler, PhD

Faith Holmes, MD

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.

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.

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. Patients who are eligible for a colonoscopy (i.e., average risk individuals between 45-80 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.

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

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

Colosense sensitivity for subjects with CRC, which is the percentage of individuals with a diagnosis of colorectal cancer that were detected as positive by the ColonoSight test.

Colosense sensitivity for subjects with AA, which is the percentage of individuals with a diagnosis of advanced adenoma that were detected as positive by the Colosense test.

Colosense sensitivity for subjects with high-grade dysplasia, which is the percentage of individuals with a diagnosis of carcinoma in situ or advanced adenoma with high grade dysplasia that were detected as positive by the Colosense test.

Colosense sensitivity for subjects with Other Adenomas (OAs), which is the percentage of individuals with a diagnosis of a non-advanced precancerous adenoma that were detected as positive by the Colosense test.

Colosense specificity for subjects with negative findings, which is the percentage of individuals with a diagnosis of benign polyps, or no findings on a colonoscopy that were detected as negative by the Colosense test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study	NCT04739722	Colorectal Canc... Advanced Adenoc... Adenoma Colon Polyp of Colon	Colosense Stool...	45 Years -	Geneoscopy, Inc.
Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study	NCT04739722	Colorectal Canc... Advanced Adenoc... Adenoma Colon Polyp of Colon	Colosense Stool...	45 Years -	Geneoscopy, Inc.
Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study	NCT04739722	Colorectal Canc... Advanced Adenoc... Adenoma Colon Polyp of Colon	Colosense Stool...	45 Years -	Geneoscopy, Inc.

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