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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric cancer group |
| ||
| Precancerous lesion group |
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| Healthy group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects aged≥40 who will receive EGD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Shen | Contact | 400-080-0660 | shen.ning1@genecast.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |