NCT04947995

Unknown

Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric...

GeneCast Biotechnology Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

D-P200110-MCCGW-HP-GC

Study Type

observational

Estimated enrollment

450

Locations

1 country

Sites

1

Timeline

Study Start

June 15, 2021

Actual (reported)

Primary Completion

June 15, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 15, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 450 participants
Study completion date: June 15, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 15, 2021
Actual (reported)
First Submitted
June 24, 2021
Actual (reported)
First Posted
July 1, 2021
Actual (reported)
Primary Completion
June 15, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 15, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 1, 2021
Status Verified: June 2021
Last Update Submitted: June 24, 2021

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 testDevice

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

Gastric cancer groupHealthy groupPrecancerous lesion group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 88 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects aged≥40 who will receive EGD.

You may qualify if:

Age≥40

Sponsors & Collaborators

GeneCast Biotechnology Co., Ltd.
Industrylead
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Othercollaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Fang YaoCONTACT13511073309 yaofang99@sina.com

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach 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

Actual (reported)

Primary Completion

June 15, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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Completed

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Phase 3Unknown

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Phase 2Unknown

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.

Contact the study team to confirm eligibility.

Study Completion

June 15, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04947995
Data provider: ClinicalTrials.gov
Source updated: 2021-07-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:10 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Gastric cancer group

Precancerous lesion group

Healthy group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations