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| Name | Class |
|---|---|
| Guangzhou Burning Rock Bioengineering Ltd. | INDUSTRY |
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ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer arm | Baseline blood samples will be collected from new diagnosis cancer participants. |
| |
| Benign disease arm | Baseline blood samples will be collected from new diagnosis benign gastric disease participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw and blood-based biomarkers analyses | Diagnostic Test | blood-based biomarkers analyses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| The differences of sensitivity and specificity in gastric cancer participants at different clinical stages. | 30 months | |
| Sensitivity and specificity for detecting gastric cancer of a cfDNA methylation-based model, in combination with other biomarkers. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of a blood miRNA-based model in detecting gastric cancer. | 30 months |
Inclusion Criteria for Cancer Arm Participants:
A. Pathologically confirmed cancer diagnosis within 42 days prior to blood draw.
B. High suspicious for cancer diagnosis by imaging tests or other routine clinical examinations, with confirmed pathological cancer diagnosis within 42 days after the blood draw.
Exclusion Criteria for Cancer Arm Participants:
Inclusion Criteria for Benign Disease Arm Participants:
A. Pathological confirmed diagnosis of benign diseases within 90 days prior to the study blood draw, with no prior treatment such as surgical resection.
B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 42 days after study blood draw.
Exclusion Criteria for Benign Disease Arm Participants:
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Eligible participants in cancer arm will be recruited with new diagnosis of gastric cancer and without any types of tumor treatment.
Eligible participants in benign disease arm will be recruited with new diagnosis of benign gastric disease and without any types of treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihong Sun, MD | Contact | +86-021-65642662 | sun.yihong@zs-hospital.sh.cn | |
| Xuefei Wang, MD | Contact | +86-021-65642662 | wang.xuefei@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yihong Sun Sun, MD | Zhongshan Hospital, Fudan University,China | Principal Investigator |
| Xuefei Wang, MD | Zhongshan Hospital, Fudan University,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZhongShan hospital FuDan university | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood
| 30 months |
| Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting gastric cancer, respectively. | 30 months |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |