Registry Platform Gastric/Esophageal Cancer (SAPHIR)

iOMEDICO

Status: Enrolling

Conditions: Esophageal Squamous Cell Carcinoma; Esophageal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Treatments: Other: Routine care as per site standard

Study type: Observational

Funder types: Industry

Identifiers

NCT04290806

IOM-090358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,900 participants in 4 patient groups

ESCC

Description:

250 patients with esophageal squamous cell carcinoma

Treatment:

Other: Routine care as per site standard

GAC

Description:

920 patients with gastric adenocarcinoma

Treatment:

Other: Routine care as per site standard

GEJAC

Description:

580 patients with gastroesophageal junction adenocarcinoma

Treatment:

Other: Routine care as per site standard

EAC

Description:

150 patients with esophageal adenocarcinoma

Treatment:

Other: Routine care as per site standard