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NCT04290806 Clinical Trial

Registry Platform Gastric/Esophageal Cancer (SAPHIR)

Esophageal Squamous Cell Carcinoma Clinical Trial

— SAPHIR  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04290806
Other study ID # IOM-090358
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 4, 2019
Est. completion date December 31, 2024

Study information
Verified date July 2023
Source iOMEDICO AG
Contact Adrian Binninger
Phone +49 761 152 42 - 0
Email info@iomedico.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 900
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Multiple sites, Gemany Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Course of treatment (treatment reality) Documentation of anamnestic data and therapy sequences 2 years per patient
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