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

NCT04722055 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1273

Last updated 2022-10-21

No results posted yet for this study

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 adenoma to CRC endures up to 10 years, providing an extended window for CRC detection and screening. Currently, fecal occult blood test (FOBT) and colonoscopy are the main diagnostic and screening methods for CRC in Chinese clinical practice. However, due to low patients' compliance with colonoscopy and poor sensitivity of FOBT, a large proportion of CRC could not be effectively diagnosed and treated at early stage. Therefore, noninvasive fecal DNA detection approach with enhanced performance is urgently needed in clinic.

The aim of this trial is to evaluate effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR) for auxiliary diagnosis of colorectal cancer. By assessing the level of DNA methylation of certain genes in human stool, the test can indicate whether cancerous and precancerous lesions exist in the areas of colon and rectum.

Conditions

  • Colorectal Cancer
  • Advanced Adenocarcinoma
  • Hyperplastic Polyp
  • Colorectal Neoplasms
  • Digestive System Neoplasm
  • Neoplasms

Interventions

DIAGNOSTIC_TEST

Multigene Methylation Detection Kit

Eligible participants are required to take stool samples for multigene methylation detection and gene sequencing, undergo colonoscopy examination, and have a biopsy when necessary (gold standard).

Sponsors & Collaborators

  • Creative Biosciences (Guangzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xianrang Song, PhD · Shandong Cancer Hospital and Institute

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2022-01-19
Completion
2022-08-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04722055 on ClinicalTrials.gov