Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer

NCT ID: NCT04947995

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2023-06-15

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Gastric cancer group

ctDNA multi-omics test

Intervention Type: DEVICE

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

Precancerous lesion group

ctDNA multi-omics test

Intervention Type: DEVICE

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

Healthy group

ctDNA multi-omics test

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

GeneCast Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ning Shen

Role: CONTACT

shen.ning1@genecast.com.cn

400-080-0660

Facility Contacts

Fang Yao

Role: primary

yaofang99@sina.com

13511073309

Other Identifiers

D-P200110-MCCGW-HP-GC

Identifier Type: -

Identifier Source: org_study_id