Registry Platform Gastric/Esophageal Cancer (SAPHIR)

NCT04290806 | Recruiting

• 1 other identifier: IOM-090358
• Study Type: observational
• Target: 1,900
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma; Esophageal Squamous Cell Carcinoma; Gastric Adenocarcinoma

Keywords

neoplasms; registry; health services research; epidemiology; Germany; palliative treatment; palliative care

Outcome Measures

Primary Outcomes (1)

• Course of treatment (treatment reality)

  Documentation of anamnestic data and therapy sequences

  2 years per patient

Study Arms (4)

ESCC

250 patients with esophageal squamous cell carcinoma

Other: Routine care as per site standard

GAC

920 patients with gastric adenocarcinoma

Other: Routine care as per site standard

GEJAC

580 patients with gastroesophageal junction adenocarcinoma

Other: Routine care as per site standard

EAC

150 patients with esophageal adenocarcinoma

Other: Routine care as per site standard

Interventions

Routine care as per site standard OTHER

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

EAC; ESCC; GAC; GEJAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• No systemic therapy for ESCC, EAC, GAC or GEJAC

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Multiple sites, Gemany

Multiple Locations, Germany

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Adenocarcinoma Of Esophagus; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Tobias Dechow, Prof.

  Ravensburg

  STUDY CHAIR

• Florian Lordick, Prof.

  Leipzig

  STUDY CHAIR

• Sylvie Lorenzen, Prof.

  München

  STUDY CHAIR

• Karin Potthoff, Dr.

  Freiburg

  STUDY CHAIR

• Anke Reinacher-Schick, Prof.

  Bochum

  STUDY CHAIR

Central Study Contacts

Adrian Binninger

CONTACT

+49 761 152 42 - 0; info@iomedico.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: December 4, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)