Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer (MONITOR- GAC)

Validation of a Plasma-based Multiomics Assay and Risk Scoring Model for Screening of Gastric Malignancies

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Device: ctDNA multi-omics test

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Ning Shen; Phone Number: 400-080-0660; Email: shen.ning1@genecast.com.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer hospital, Chinese Academy of Medical Sciences
      • Contact: Fang Yao; Phone Number: 13511073309; Email: yaofang99@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects aged≥40 who will receive EGD.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy group	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.
Gastric cancer group	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.
Precancerous lesion group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GeneCast Biotechnology Co., Ltd.
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: D-P200110-MCCGW-HP-GC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No