SAPHIR
Registry Platform Gastric/Esophageal Cancer (SAPHIR)
Rekrutierend
NCT-Nummer:
NCT04290806
Studienbeginn:
Dezember 2019
Letztes Update:
08.08.2024
Wirkstoff:
-
Indikation (Clinical Trials):
Adenocarcinoma, Esophageal Squamous Cell Carcinoma
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
iOMEDICO AG
Collaborator:
-
Studienleiter
Tobias Dechow, Prof. Study ChairRavensburg
Florian Lordick, Prof. Study ChairLeipzig
Sylvie Lorenzen, Prof. Study ChairMünchen
Karin Potthoff, Dr. Study ChairFreiburg
Anke Reinacher-Schick, Prof. Study ChairBochum
Kontakt
Adrian Binninger Kontakt: Phone: +49 761 152 42 - 0 E-Mail: info@iomedico.com» Kontaktdaten anzeigen
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.
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 cycleExclusion Criteria: - No systemic therapy for ESCC, EAC, GAC or GEJAC
Primary outcome: 1. Course of treatment (treatment reality) (Time Frame - 2 years per patient):Documentation of anamnestic data and therapy sequences
ESCC250 patients with esophageal squamous cell carcinoma GAC250 patients with gastric adenocarcinoma GEJAC250 patients with gastroesophageal junction adenocarcinoma EAC150 patients with esophageal adenocarcinoma
Routine care as per site standard:Physician's choice according to patient's needs. Routine care as per site standard.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Registry Platform Gastric/Esophageal Cancer (SAPHIR)"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (* ) gekennzeichneten Angaben müssen eingetragen werden!