Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer

• Conditions: Gastric Cancer
• Interventions: Device: ctDNA multi-omics test

• Registration Number: NCT04947995
• Lead Sponsor: GeneCast Biotechnology Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-15
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Age≥40
• Received EGD;
• Subjects must have given written informed consent, and the subjects compliance are good.

Exclusion Criteria

• Subjects who could not accept EGD;
• Subjects who had previously undergone total or partial gastrectomy;
• There are other serious acute or chronic medical or mental diseases or laboratory abnormalities that may interfere with the interpretation of the research results and make the subjects unsuitable for the study in the judgment of the researchers;
• Subjects with a history of malignant tumor or two or more malignant tumors at the same time;
• Pregnant subjects;
• Subjects who had a history of bone marrow or organ transplantation, or had a history of blood transfusion one month before enrollment.
• The subjects with incomplete clinical data collection or other reasons judged by the researchers are not suitable for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy group	ctDNA multi-omics test	-
Gastric cancer group	ctDNA multi-omics test	-
Precancerous lesion group	ctDNA multi-omics test	-

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of blood-based multi-omics assay for early detection of gastric cancer with comparison to EGD and/or histological diagnosis.	24 months

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China