NCT05431621

Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers

Completed Last updated 29 January 2025

What this trial tests

trial in Esophageal Cancer in 2,430 participants. Completed in 31 July 2023.

Timeline

15 November 2020

Primary endpoint
30 June 2023

31 July 2023

Quick facts

Lead sponsor	Shanghai Zhongshan Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,430
Start date	15 November 2020
Primary completion	30 June 2023
Estimated completion	31 July 2023
Sites	4 locations across China

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →
• Gastric (Stomach) Cancer — all drugs for Gastric (Stomach) Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Shanghai Zhongshan Hospital

Who can join

Adults 18 to 80, any sex, with Esophageal Cancer or Gastric (Stomach) Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single blind, case control, multicenter study jointly developed by Zhongshan Hospital of Fudan University, Shanghai Public Health Clinical Center, Shanghai Xuhui Central Hospital, Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, and Shanghai Singlera Genomics Company. The enrolled population will include positive group, precancerous lesions and healthy control group, which is expected to enroll 2,430 participants. The primary objective is to establish molecular testing methods for non-invasive screening and early diagnosis of digestive system cancers through ctDNA methylation and mutation, cfDNA and ctDNA fragment size, and end motif based model (for esophageal, gastric, colorectal cancer), and through ctDNA methylation detection, ctDNA low-pass WGS, miRNA7 and CTC detection and analysis technology based model (for hepatocellular carcinoma). The sensitivity and specificity of the models in cancer early detection will be evaluated.

Publications & conference data

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

1. Risk stratification and early detection biomarkers for precision HCC screening.
   Lee YT, Fujiwara N, Yang JD, Hoshida Y. · · 2023 · cited 90× · PMID 36082510 · DOI 10.1002/hep.32779
2. The role of microRNAs in the gastric cancer tumor microenvironment.
   Yu X, Zhang Y, Luo F, Zhou Q, et al · · 2024 · cited 52× · PMID 39164671 · DOI 10.1186/s12943-024-02084-x
3. Targeting miRNAs and Other Non-Coding RNAs as a Therapeutic Approach: An Update.
   Bayraktar E, Bayraktar R, Oztatlici H, Lopez-Berestein G, et al · · 2023 · cited 51× · PMID 37104009 · DOI 10.3390/ncrna9020027
4. 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
5. Early detection and prognosis evaluation for hepatocellular carcinoma by circulating tumour DNA methylation: A multicentre cohort study.
   Guo DZ, Huang A, Wang YC, Zhou S, et al · · 2024 · cited 19× · PMID 38741204 · DOI 10.1002/ctm2.1652
6. Clinical applications and perspectives of circulating tumor DNA in gastric cancer.
   Li JH, Zhang DY, Zhu JM, Dong L. · · 2024 · cited 14× · PMID 38184573 · DOI 10.1186/s12935-024-03209-4
7. GUIDE: a prospective cohort study for blood-based early detection of gastrointestinal cancers using targeted DNA methylation and fragmentomics sequencing.
   Huang A, Guo DZ, Su ZX, Zhong YS, et al · · 2025 · cited 6× · PMID 40468355 · DOI 10.1186/s12943-025-02367-x
8. Blood biomarkers of hepatocellular carcinoma: a critical review.
   Zhao J, Hu Z, Zheng X, Lin Y, et al · · 2024 · cited 4× · PMID 39650722 · DOI 10.3389/fcell.2024.1489836