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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    900
  • sponsor
    iOMEDICO AG
Updated on 15 June 2022
cancer
esophageal cancer
antineoplastic agents
antineoplastic
esophagus cancer
squamous cell carcinoma of esophagus

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.

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.

Details
Condition Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
Treatment Routine care as per site standard
Clinical Study IdentifierNCT04290806
SponsoriOMEDICO AG
Last Modified on15 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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