Registry for gastric and esophageal cancer treatments in Germany
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
This study is collecting information on how patients in Germany with advanced esophageal and stomach cancers are treated to see how well different treatments work in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT04290806 on ClinicalTrials.gov |
What this trial studies
The SAPHIR registry collects and analyzes data on the treatment of patients with metastatic esophageal, gastric, or gastroesophageal junction cancer in Germany. This national, observational study follows patients for up to two years, documenting their treatment regimens, patient characteristics, and health-related quality of life. By tracking therapeutic sequences and treatment changes, the registry aims to provide insights into real-world treatment practices and outcomes for these cancers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed stage IV esophageal, gastric, or gastroesophageal junction cancer who are planned for palliative systemic therapy.
Not a fit: Patients who are not receiving systemic therapy for their cancer will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could improve understanding of treatment effectiveness and patient outcomes for metastatic gastric and esophageal cancers.
How similar studies have performed: Other observational studies have successfully utilized registry approaches to improve treatment understanding and patient outcomes in oncology, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Multiple Locations
- Multiple sites, Gemany — Multiple Locations, Germany (Recruiting)
Study contacts
- Study coordinator: Adrian Binninger
- Email: info@iomedico.com
- Phone: +49 761 152 42 - 0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.