Registry Platform Gastric/Esophageal Cancer (SAPHIR) (SAPHIR)

January 26, 2026 updated by: iOMEDICO AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Multiple Locations, Germany
        • Recruiting
        • Multiple sites, Gemany
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.
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.
GAC
920 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
580 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of treatment (treatment reality)
Time Frame: 2 years per patient
Documentation of anamnestic data and therapy sequences
2 years per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Study Chair: Tobias Dechow, Prof., Ravensburg
  • Study Chair: Florian Lordick, Prof., Leipzig
  • Study Chair: Sylvie Lorenzen, Prof., München
  • Study Chair: Karin Potthoff, Dr., Freiburg
  • Study Chair: Anke Reinacher-Schick, Prof., Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2019

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-090358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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