Registry Platform Gastric/Esophageal Cancer (SAPHIR)

Rekrutierend

NCT-Nummer:
NCT04290806

Studienbeginn:
Dezember 2019

Letztes Update:
10.07.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Adenocarcinoma, Esophageal Squamous Cell Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
iOMEDICO AG

Collaborator:
-

Studienleiter

Tobias Dechow, Prof.
Study Chair
Ravensburg

Florian Lordick, Prof.
Study Chair
Leipzig

Sylvie Lorenzen, Prof.
Study Chair
München

Karin Potthoff, Dr.
Study Chair
Freiburg

Anke Reinacher-Schick, Prof.
Study Chair
Bochum

Kontakt

Adrian Binninger
Kontakt:
Phone: +49 761 152 42 - 0
E-Mail: info@iomedico.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Multiple sites, Gemany
Multiple Locations
GermanyRekrutierend» Google-Maps
Ansprechpartner:
iOMEDICO
Phone: +49761152420
E-Mail: info@iomedico.com» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Course of treatment (treatment reality) (Time Frame - 2 years per patient):
Documentation of anamnestic data and therapy sequences

Studien-Arme

ESCC
250 patients with esophageal squamous cell carcinoma
GAC
250 patients with gastric adenocarcinoma
GEJAC
250 patients with gastroesophageal junction adenocarcinoma
EAC
150 patients with esophageal adenocarcinoma

Geprüfte Regime

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

Quelle: ClinicalTrials.gov