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Registry Platform Gastric/Esophageal Cancer (SAPHIR)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04290806
Acronym
SAPHIR
Enrollment
1900
Registered
2020-03-02
Start date
2019-12-04
Completion date
2028-12-31
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Keywords

neoplasms, registry, health services research, epidemiology, Germany, palliative treatment, palliative care

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.

Interventions

OTHERRoutine care as per site standard

Physician's choice according to patient's needs. Routine care as per site standard.

Sponsors

iOMEDICO AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Course of treatment (treatment reality)2 years per patientDocumentation of anamnestic data and therapy sequences

Countries

Germany

Contacts

CONTACTAdrian Binninger
info@iomedico.com+49 761 152 42 - 0
STUDY_CHAIRTobias Dechow, Prof.

Ravensburg

STUDY_CHAIRFlorian Lordick, Prof.

Leipzig

STUDY_CHAIRSylvie Lorenzen, Prof.

München

STUDY_CHAIRKarin Potthoff, Dr.

Freiburg

STUDY_CHAIRAnke Reinacher-Schick, Prof.

Bochum

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026