Colorectal cancer screening using a stool DNA-based SDC2 methylation test: a multicenter, prospective trial

Area of Science:

• Oncology
• Molecular Diagnostics
• Gastroenterology

Background:

• Colorectal cancer (CRC) screening is crucial for prevention and early detection.
• Current screening methods like colonoscopy have low adherence due to invasiveness and preparation requirements.
• Non-invasive tests like fecal occult blood tests have limited sensitivity.

Purpose of the Study:

• To validate the clinical performance of a stool-based DNA marker, Syndecan-2 (SDC2) methylation, for early CRC detection in asymptomatic populations.
• To assess the utility of the EarlyTect™-Colon Cancer test in a broader screening context.

Main Methods:

• Participants provided stool samples (≥20g) prior to screening colonoscopy.
• Stool DNA was isolated, bisulfite-treated, and analyzed for SDC2 methylation using real-time PCR.
• Results were compared to colonoscopy findings and histopathology; participants were categorized into CRC, polyp, or negative groups.

Main Results:

• Previous studies demonstrated >90% sensitivity and specificity for SDC2 methylation in detecting CRC.
• This trial aims to confirm these findings in a larger, asymptomatic screening population.
• Clinical data including age, sex, and colonoscopy results were recorded.

Conclusions:

• The trial investigates the quantitative detection of SDC2 methylation in stool DNA for CRC screening.
• Positive results are expected to support the use of this marker for early CRC detection.
• This non-invasive test could potentially make colonoscopy a more selective procedure for high-risk individuals.