CompletedNot Applicable

A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population

China12,106 participantsStarted 2021-03-22

Plain-language summary

to determine screening value of stool-based SDC2 DNA methylation test for advanced colorectal neoplasia in the asymptomatic Chinese community population.

Who can participate

Age range45 Years – 75 Years

SexALL

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Inclusion criteria

✓. Asymptomatic screening individual (no alarm features predicting colorectal cancer including hematochezia, melena, anemia of unknown cause, weight loss, abdominal mass, a positive result of digital rectal examination)
✓. Age between 45 to 75 years old, the gender is not limited
✓. Willing to participate and sign informed consent

Exclusion criteria

✕. Patients with contraindications for bowel preparation or colonoscopy
✕. Patients with known colorectal adenoma or serrated lesions
✕. History of colonoscopy within 5 years or polypectomy
✕. Patients with inflammatory bowel disease
✕. History of CRC and patients clinically highly suspected with colorectal cancer
✕. History of hereditary CRC syndrome (including polyposis)
✕. Patients taking anticoagulants such as aspirin and warfarin within 7 days, or who have coagulopathy
✕. Pregnancy, or severe organ insufficiency (heart, lung, or kidney et al)

What they're measuring

Detection of advanced colorectal neoplasia

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT04786704

SponsorChanghai Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-15

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