Status:

COMPLETED

A Multicenter Clinical Trial of Stool-based DNA Testing for Early Detection of Colon Cancer in China

Lead Sponsor:

Creative Biosciences (Guangzhou) Co., Ltd.

Conditions:

Colorectal Cancer

Advanced Adenocarcinoma

Eligibility:

All Genders

40-79 years

Brief Summary

According to data from Global Cancer Statistics 2018, colorectal cancer (CRC) ranks second in incidence and fifth in mortality among all cancers in China. The underlying neoplastic progression from ad...

Detailed Description

The multicenter clinical trial will be conducted using a single-blind method. Stool samples provided by participants will be evaluated by Human Multigene Methylation Detection Kit (Fluorescent PCR). T...

Eligibility Criteria

Inclusion

  • Participants must also meet the following three criteria to be included in this study:
  • To be 40 to 79 years old, regardless of gender;
  • To participate voluntarily and sign Informed Consent Form;
  • To satisfy any of the following three conditions:
  • Patients with colorectal cancer confirmed or suspected by colonoscopy or pathological biopsy;
  • Patients with gastrointestinal disease or normal population to be examined by colonoscopy;
  • Patients who are planning to undergo colonoscopy or have colonoscopy results from other interfering diseases.

Exclusion

  • Patients with any of the following conditions shall be excluded:
  • To have had radical resection of colorectal cancer before enrollment in this study;
  • To have been deemed ineligible to participate in the study by the principal investigator due to various other reasons.

Key Trial Info

Start Date :

January 26 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 8 2022

Estimated Enrollment :

1273 Patients enrolled

Trial Details

Trial ID

NCT04722055

Start Date

January 26 2021

End Date

August 8 2022

Last Update

October 21 2022

Active Locations (1)

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Shandong Cancer Hospital and Institute

Jinan, Shandong, China