MedTrace Logo

Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer

NCT05336058 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1140

Last updated 2024-04-22

No results posted yet for this study

Summary

This was a case control, non-intervention study jointly developed by Fudan University Cancer Hospital and Shanghai Singlera Genomics Company. The enrolled population was screened by gastric surgery, including gastric cancer, precancerous lesions, benign lesions, and healthy control group. 10ml of whole blood of the enrolled subjects was collected for multi-target PCR detection of cfDNA methylation. The objective is to explore the clinical performance of polygene methylation (PCR-fluorescence probe) in the adjunctive diagnosis of gastric cancer, including the sensitivity of detection of various types and stages of gastric cancer, the specificity of detection of healthy controls, precancerous states, precancerous lesions, and the detection interference of other cancers. The diagnostic performance will be compared with CA199, CEA and CA724. The research data will provide a basis for screening targets for the development of detection kits.

Conditions

  • Stomach Cancer

Interventions

OTHER

No intervention

In this non-intervention study, 10ml of whole blood of enrolled subjects was collected for multi-target PCR detection of cfDNA methylation.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Singlera Genomics Inc.

    lead INDUSTRY

Principal Investigators

  • Rui Liu, PhD · Singlera Genomics Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-02-04
Completion
2024-02-04

Countries

  • China

Study Locations

More Related Trials

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 NCT05336058 on ClinicalTrials.gov