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

June 24, 2021 updated by: GeneCast Biotechnology Co., Ltd.

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GeneCast Biotechnology Co., Ltd.

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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