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NCT05558436

Comparison of Diagnostic Sensitivity Between ctDNA Methylation and CEA in Colorectal Cancer

Active, enrolled Last updated 10 May 2024
What this trial tests

trial testing Genome-wide methylation profiling in Colorectal Tumor in 662 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 June 2022
Primary endpoint
1 May 2024
31 December 2024

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment662
Start date1 June 2022
Primary completion1 May 2024
Estimated completion31 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 18 to 80, any sex, with Colorectal Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective diagnostic study. This study is to compare the performance between circulating tumor DNA (ctDNA) methylation and carcinoembryonic antigen (CEA) in detecting colorectal tumor. Firstly, based on the identification of differential ctDNA methylation biomarkers, the diagnostic model is established and the diagnostic performance was compared with that of CEA. Secondly, the stage stratification model was established preliminarily based on differential ctDNA methylation biomarkers and the performance was also compared with that of CEA.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Circulating tumor DNA methylation detection as biomarker and its application in tumor liquid biopsy: advances and challenges.
    Li L, Sun Y. · · 2024 · cited 52× · PMID 39525954 · DOI 10.1002/mco2.766
  2. Current Applications of Liquid Biopsy in Gastrointestinal Cancer Disease-From Early Cancer Detection to Individualized Cancer Treatment.
    David P, Mittelstädt A, Kouhestani D, Anthuber A, et al · · 2023 · cited 10× · PMID 37046585 · DOI 10.3390/cancers15071924
  3. Circulating tumor DNA methylation-based method for noninvasive detection and stage stratification of colorectal tumor.
    Ji H, Xu M, Jiang W, Hu Y, et al · · 2026 · PMID 41796341 · DOI 10.1186/s13148-026-02097-x
  4. Preoperative Identification of Lymph Node Metastasis in Colorectal Cancer Using Noninvasive Circulating Tumor DNA Methylation Signatures: Results From a Prospective Study.
    Ji H, Xu M, Hu Y, Yan B, et al · · 2026 · PMID 41378988 · DOI 10.1097/dcr.0000000000004089

Verify or expand the search:

Other recruiting trials for Colorectal Tumor

Currently open trials in the same condition.

Other Nanfang Hospital, Southern Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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