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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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Prospective multicenter longitudinal (observational) study recruiting from tertiary centers for the surgical management of esophageal cancer; Virginia Mason Medical Center (Seattle, USA) and St Mary's Hospital (Imperial College, London, UK). This is intended to be a pilot study.
Patients undergoing curative treatment for esophageal cancer will be recruited at the time of routine clinical assessment shortly following initial diagnosis and will undergo clinical and radiological evaluation at two study time points: (1) staging investigation (e.g. laparoscopy or endoscopy) and (2) definitive surgical resection. Study time points have been judiciously chosen to coincide with interventions that form part of patient's routine clinical care. It is intended that sampling will occur on the day of each intervention/surgery following a routine period of fasting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Body Composition | Radiologic assessment of fat and muscle components of body composition at presentation and following initial treatment for esophageal cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal variation in body composition | Establish the effect of patient and disease-specific factors on body composition in a global cohort of patients undergoing esophagectomy for cancer | Approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and disease-specific factors | Provide a benchmark for future reporting of body composition and to explore the association between body composition and outcomes of esophageal cancer surgery | Approximately 1 year |
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Inclusion Criteria:
Patients with the following characteristics will be eligible for inclusion in this study:
Exclusion Criteria:
Patients with the following characteristics will not be eligible for inclusion in this study:
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International cohort of patients presenting with regional {Stage 2 and 3} esophageal cancer who are considered appropriate candidates for surgical therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Donald E Low, MD | Virginia Mason Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
Patient characteristics will be pulled out by three regions, North America, Europe and Asia. Additional anonymized data may be available upon request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2019 | Mar 11, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2019 | Mar 11, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |