Registry Platform Gastric/Esophageal Cancer (SAPHIR)

Recruiting

• Conditions: Esophageal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Gastric Adenocarcinoma
• Interventions: Other: Routine care as per site standard

• Registration Number: NCT04290806
• Lead Sponsor: iOMEDICO AG

Brief Summary

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.

Study Timeline

• Study Start: 2019-12-04
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-21
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EAC	Routine care as per site standard	150 patients with esophageal adenocarcinoma
ESCC	Routine care as per site standard	250 patients with esophageal squamous cell carcinoma
GEJAC	Routine care as per site standard	250 patients with gastroesophageal junction adenocarcinoma
GAC	Routine care as per site standard	250 patients with gastric adenocarcinoma

Primary Outcome Measures

Name	Time	Method
Course of treatment (treatment reality)	2 years per patient	Documentation of anamnestic data and therapy sequences

Trial Locations

Locations (1)

Multiple sites, Gemany; 🇩🇪 Multiple Locations, Germany