Gastric CancerMONITOR- GACNCT04947995
Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer
An observational study of Gastric Cancer, run by GeneCast Biotechnology Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- ctDNA multi-omics test
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2021to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects aged≥40 who will receive EGD.
Who may be able to join
- Age≥40
- Received EGD;
- Subjects must have given written informed consent, and the subjects compliance are good.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fang Yao, 13511073309, yaofang99@sina.com
About this study
Official title: 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.
- Conditions
- Gastric Cancer
- Being tested
- ctDNA multi-omics test
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer group | Not described Receives: Device: ctDNA multi-omics test | |
| Precancerous lesion group | Not described Receives: Device: ctDNA multi-omics test | |
| Healthy group | Not described Receives: Device: ctDNA multi-omics test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of blood-based multi-omics assay for early detection of gastric cancer with comparison to EGD and/or histological diagnosis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start15 Jun 2021
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneCast Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947995
- Sponsor's protocol ID
- D-P200110-MCCGW-HP-GC
- Acronym
- MONITOR- GAC
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Plasma-based Multiomics Assay and Risk Scoring Model for Screening of Gastric Malignancies
- ClinicalTrials.gov ID
- NCT04947995
- Acronym / sponsor ID
- MONITOR- GAC / D-P200110-MCCGW-HP-GC
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- GeneCast Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer group | – | Device: ctDNA multi-omics test |
| Precancerous lesion group | – | Device: ctDNA multi-omics test |
| Healthy group | – | Device: ctDNA multi-omics test |
Who may qualify
- Ages
- 40 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged≥40 who will receive EGD.
Key inclusion criteria (3 listed)
- Age≥40
- Received EGD;
- Subjects must have given written informed consent, and the subjects compliance are good.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ctDNA multi-omics testThe ctDNA multi-omics test for gastric cancer will be built based on low-pass WGS, methylation, and target region sequencing. | Device | Gastric cancer group, Healthy group, Precancerous lesion group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by GeneCast Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Shen (400-080-0660, shen.ning1@genecast.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.