Registry Platform Gastric/Esophageal Cancer (SAPHIR)

Sponsor

iOMEDICO AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04290806

Collaborator

(none)

900

Enrollment

Location

60.9

Anticipated Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Esophageal Adenocarcinoma	Other: Routine care as per site standard

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

900 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Dec 4, 2019

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
ESCC 250 patients with esophageal squamous cell carcinoma	Other: Routine care as per site standard Physician's choice according to patient's needs. Routine care as per site standard.
GAC 250 patients with gastric adenocarcinoma	Other: Routine care as per site standard Physician's choice according to patient's needs. Routine care as per site standard.
GEJAC 250 patients with gastroesophageal junction adenocarcinoma	Other: Routine care as per site standard Physician's choice according to patient's needs. Routine care as per site standard.
EAC 150 patients with esophageal adenocarcinoma	Other: Routine care as per site standard Physician's choice according to patient's needs. Routine care as per site standard.

Outcome Measures

Primary Outcome Measures

Course of treatment (treatment reality) [2 years per patient]
Documentation of anamnestic data and therapy sequences

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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