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Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer

NCT04947995 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2021-07-01

No results posted yet for this study

Summary

This is a prospective, case-control study intended to develop and validate a blood-based multi-omics assay and computational model for early detection of gastric cancer. Approximately 450 subjects who receive esophageogastroscopy (EGD) will be enrolled and assigned to three arms including gastric cancer, precancerous lesion, and healthy control based on the diagnosis of EGD and histological results. Cell free DNA will be extracted from peripheral blood of all participants and assayed by next-generation sequencing for biomarkers including somatic mutation, methylation, and chromosome instability signals. In the first stage a multi-omics models will be developed for classification between malignancy group and control groups, and between precancerous group and healthy control. Sensitivity and specificity of the model will be evaluated in an independent validation group in the second stage.

Conditions

Interventions

DEVICE

ctDNA multi-omics test

The ctDNA multi-omics test for gastric cancer will be built based on low-pass WGS, methylation, and target region sequencing.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • GeneCast Biotechnology Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
40 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-06-15
Completion
2023-06-15

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 NCT04947995 on ClinicalTrials.gov