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The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic esophageal, gastric or gastroesophageal junction cancer, treated in palliative intention in daily routine practice in Germany.
SAPHIR is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic esophageal, gastric or gastroesophageal junction Cancer in Germany. The registry will follow patients for up to two years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
Health-related quality of life (HRQoL) will be evaluated for up to two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESCC | 250 patients with esophageal squamous cell carcinoma |
| |
| GAC | 920 patients with gastric adenocarcinoma |
| |
| GEJAC | 580 patients with gastroesophageal junction adenocarcinoma |
| |
| EAC | 150 patients with esophageal adenocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine care as per site standard | Other | Physician's choice according to patient's needs. Routine care as per site standard. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Course of treatment (treatment reality) | Documentation of anamnestic data and therapy sequences | 2 years per patient |
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Inclusion Criteria:
Histologically proven stage IV (metastatic) ESCC, EAC, GAC or GEJAC
Planned palliative systemic first-line therapy
Age >= 18 years
Signed informed consent (IC)
Exclusion Criteria:
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Adult patients with metastatic (stage IV) esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), gastric adenocarcinoma (GAC) or gastroesophageal junction adenocarcinoma (GEJAC), requiring palliative systemic first-line therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrian Binninger | Contact | +49 761 152 42 - 0 | info@iomedico.com |
| Name | Affiliation | Role |
|---|---|---|
| Tobias Dechow, Prof. | Ravensburg | Study Chair |
| Florian Lordick, Prof. | Leipzig | Study Chair |
| Sylvie Lorenzen, Prof. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple sites, Gemany | Recruiting | Multiple Locations | Germany |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| C562730 | Adenocarcinoma Of Esophagus |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| München |
| Study Chair |
| Karin Potthoff, Dr. | Freiburg | Study Chair |
| Anke Reinacher-Schick, Prof. | Bochum | Study Chair |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |