Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer

NCT04947995 | Unknown

• 1 other identifier: D-P200110-MCCGW-HP-GC
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Gastric cancer group

Device: ctDNA multi-omics test

Precancerous lesion group

Device: ctDNA multi-omics test

Healthy group

Device: ctDNA multi-omics test

Interventions

ctDNA multi-omics test DEVICE

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

Gastric cancer group; Healthy group; Precancerous lesion group

Eligibility Criteria

• Age: 40 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects aged≥40 who will receive EGD.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Ning Shen

CONTACT

400-080-0660; shen.ning1@genecast.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: June 15, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)