Status:

COMPLETED

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

Lead Sponsor:

Changhai Hospital

Collaborating Sponsors:

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Gongli Hospital of Shanghai Pudong New Area

Conditions:

Colorectal Cancer

Colorectal Neoplasm

Eligibility:

All Genders

45-75 years

Brief Summary

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

Detailed Description

In China, colorectal cancer (CRC) remains to be the leading cancer of the digestive system. According to nationwide cancer statistics using population-based cancer registry data in China, age-standard...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

March 22 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 25 2022

Estimated Enrollment :

12106 Patients enrolled

Trial Details

Trial ID

NCT04786704

Start Date

March 22 2021

End Date

June 25 2022

Last Update

June 28 2022

Active Locations (1)

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Changhai Hospital

Shanghai, Shanghai Municipality, China, 200433