NCT03828396

Diagnosis of Colorectal Cancer and Advanced Adenoma Using Cancer-specific Methylation Signatures

Status unknown Last updated 4 February 2019

What this trial tests

trial in Colorectal Cancer in 1,300 participants. Status unknown.

Timeline

26 October 2018

Primary endpoint
30 September 2019

30 September 2020

Quick facts

Lead sponsor	Shanghai Zhongshan Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,300
Start date	26 October 2018
Primary completion	30 September 2019
Estimated completion	30 September 2020
Sites	1 location across China

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Advanced Adenoma — all drugs for Advanced Adenoma →

Sponsor

Shanghai Zhongshan Hospital

Who can join

Adults 45 to 80, any sex, with Colorectal Cancer or Advanced Adenoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Colorectal cancer is a common malignant tumor of the digestive tract. It is still a challenging task to detect colorectal cancer at an early stage. Studies have found that DNA methylation has a relationship with the occurrence and development of tumors. Singlera Genomics Inc. has invented the proprietary methyl-Titan sequencing technology and developed a detection method for colorectal cancer and advanced adenoma (Adenoma/Colorectal cancer Early detection, ACE) using the cancer-specific methylation markers. ACE is a blood-based non-invasive diagnostic technique. It has high compliance rate compared with colonoscopy, and sampling is more convenient than stool testing. It also has much higher sensitivity compared to existing blood testing methods.

The current study plans to use ACE method to analyze ctDNA in the blood for the cancer-specific DNA methylation markers to aid in the differential diagnosis of patients with colorectal cancer or adenoma. This technique will greatly reduce the discomfort in the diagnosis of suspected patients and improve the diagnosis of high-risk population of colorectal cancer.

The goals of this study are: 1) to establish a detection system based on plasma ctDNA methylation sequencing technology for the auxiliary diagnosis of colorectal cancer and adenoma, 2) to assess the diagnostic value of plasma ctDNA methylation signature for colorectal cancer and adenoma, and 3) to assess the association of plasma ctDNA methylation signals with colonoscopy results and pathological results of surgical specimens.

A total of 1300 patients (700 cases positive and 600 cases negative) aging between 45 and 80 years old will be enrolled. Colonoscopy will be performed to determine whether patients are positive or negative. Positive patients who need surgical resection will be further classified according to their surgical histopathological results. For negative patients, the type of lesion will be clarified. The plasma samples of all subjects will be analyzed for cancer-specific ctDNA methylation profiles. Based on the results of plasma ctDNA methylation test, the risks of colorectal cancer of the enrolled subjects are scored. Combined with the grouping information, the clinical application value of the cancer-specific methylation profile for early cancer diagnosis will be assessed.

Publications & conference data

2 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. Screening for pancreatic cancer has the potential to save lives, but is it practical?
   Mazer BL, Lee JW, Roberts NJ, Chu LC, et al · · 2023 · cited 23× · PMID 37212770 · DOI 10.1080/17474124.2023.2217354