Registry Platform Gastric/Esophageal Cancer (SAPHIR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Routine care as per site standard.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Research Platform For Molecular Testing, Treatment, Quality Of Life And Outcome Of Patients With Esophageal, Gastric Or Gastroesophageal Junction Cancer Requiring Palliative Systemic Therapy
Overview
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.
Detailed description
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.
Interventions
- Other Routine care as per site standard
Physician's choice according to patient's needs. Routine care as per site standard.
Primary outcome measures
- Course of treatment (treatment reality) [Time frame: 2 years per patient]
Eligibility criteria
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)
- Patients answering questionnaires: IC before first therapy cycle
- Patients not answering questionnaires: IC latest 4 weeks after start of first therapy cycle
Exclusion criteria
- No systemic therapy for ESCC, EAC, GAC or GEJAC
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Multiple sites, Gemany — Multiple Locations
Identifiers
NCT: NCT04290806 · IOM-090358