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To identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.
Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2 positive cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ctDNA screening | Genetic | Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in molecular biomarkers at time on best overall response | Molecular biomarkers including gene mutation, amplification and fusion were detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from patients during treatment. The list of genes included in OncoScreen Plus panelTM is provided as supplementary file. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in molecular biomarkers at time on disease progression | Molecular biomarkers including gene mutation, amplification and fusion were detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from patients during treatment. The list of genes included in OncoScreen Plus panelTM is provided as supplementary file. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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HER2 positive gastric cancer patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Liu | Contact | +86-18001753364 | liujing23@vip.163.com | |
| Chenfei Zhou | Contact | +86-13761618390 | raining_grayday@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Ruijin Hospital | Recruiting | Shanghai | 200025 | China |
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