Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance (PROVE)

Universal Diagnostics

Status: Enrolling

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07310446

CRC-US-002

Details and patient eligibility

About

This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.

Full description

The Sponsor has identified cfDNA (circulating free-DNA) alterations (including methylation, fragmentation, and copy-number variance) that allow specific detection of colorectal cancer (CRC) advanced precancerous lesions (APL) and is in the process of developing a bloodbased test for early detection of colorectal cancer. The Sponsor is performing the current study to evaluate and optimize the performance of a preliminary panel of markers to finalize the assay for the use for US population. This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pre- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.

Enrollment: 6,500 estimated patients

Sex: All

Ages: 45 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Arm A: Diagnosed with CRC
• Arm B: Undergoing screening with colonoscopy for CRC

Exclusion criteria

• Arm A: Undergoing treatment for CRC,
• Arm B: Past history of CRC

Trial design

6,500 participants in 2 patient groups

Arm A

Description:

Patients newly diagnosed with CRC who have not yet had treatment or surgery.

Arm B

Description:

People at average risk of CRC undergoing screening for colorectal cancer with colonoscopy.