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

NCT05431621 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2430

Last updated 2025-01-29

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Xuhui Central Hospital, Shanghai

    collaborator OTHER

  • Changhai Hospital

    collaborator OTHER

  • Hubei Cancer Hospital

    collaborator OTHER

  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV

  • Singlera Genomics Inc.

    collaborator INDUSTRY

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Jian Zhou, Doctor · Fudan University

  • Yunshi Zhong, Doctor · Fudan University

  • Rui Liu, Doctor · Singlera Genomics Inc.

  • Bin Yan, Doctor · Shanghai Zhongshan Hospital

  • Dongli He, Master · Xuhui Central Hospital, Shanghai

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2023-06-30
Completion
2023-07-31

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 NCT05431621 on ClinicalTrials.gov