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This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Surgical resection + perioperative chemotherapy |
| ||
| Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery |
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| Cohort 3: Definitive chemoradiotherapy |
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| Cohort 4: Chemotherapy with the aim to prolong life expectancy |
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| Cohort 5: Non-chemotherapeutic palliation | E.g. Palliative radiotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circulating tumor DNA | Diagnostic Test | Measurement of circulating tumor DNA from plasma over a period of 2 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | 1 year | |
| Overall survival | 5 year | |
| Response rate RECIST 1.1 |
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Inclusion Criteria:
Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent
Exclusion Criteria:
Patients not providing informed consent
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The study population includes patients with gastroesophageal cancer in five prospective cohorts. Neither WGS/WES on primary tumor nor serial blood samples for ctDNA are mandatory for inclusion in the study. However, it is highly encouraged to perform WGS/WES of the primary tumor. A retrospective cohort will be open for inclusion to facilitate initial hypothesis testing to be validated in the prospective cohorts
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morten Mau-Sørensen, MD, PhD | Contact | 35450879 | 0045 | mms@rh.regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| through study completion, an average of 1 year |
| Response duration RECIST 1.1 | through study completion, an average of 1 year |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |