Clinical trial NCT04290806: Registry Platform Gastric/Esophageal Cancer (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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Squamous Cell Carcinoma
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
Keywords: neoplasms
registry
health services research
epidemiology
Germany
palliative treatment
palliative care
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2020-03-02
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with metastatic (stage IV) esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), gastric adenocarcinoma (GAC) or gastroesophageal junction adenocarcinoma (GEJAC), requiring palliative systemic first-line therapy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Course of treatment (treatment reality)
timeFrame: 2 years per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites, Gemany
Study officials:
affiliation: Ravensburg
name: Tobias Dechow, Prof.
role: STUDY_CHAIR
affiliation: Leipzig
name: Florian Lordick, Prof.
role: STUDY_CHAIR
affiliation: München
name: Sylvie Lorenzen, Prof.
role: STUDY_CHAIR
affiliation: Freiburg
name: Karin Potthoff, Dr.
role: STUDY_CHAIR
affiliation: Bochum
name: Anke Reinacher-Schick, Prof.
role: STUDY_CHAIR
References: