Esophageal Squamous Cell CarcinomaSAPHIRNCT04290806
Registry Platform Gastric/Esophageal Cancer (SAPHIR)
An observational study of Esophageal Squamous Cell Carcinoma and Gastric Adenocarcinoma, run by iOMEDICO AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Routine care as per site standard
- How many people
- 1,900 participants
- Where
- 1 siteGermany
- Study dates
- 4 Dec 2019to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No systemic therapy for ESCC, EAC, GAC or GEJAC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Multiple sites, Gemany
Multiple Locations
iOMEDICO, +49761152420, info@iomedico.com
About this study
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
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.
Read the 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.
- Conditions
- Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Being tested
- Routine care as per site standard
- Keywords
- neoplasms, registry, health services research, epidemiology, Germany, palliative treatment, palliative care
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine care as per site standardOther
Physician's choice according to patient's needs. Routine care as per site standard.
| Study group | Role | What they receive |
|---|---|---|
| ESCC | 250 patients with esophageal squamous cell carcinoma Receives: Other: Routine care as per site standard | |
| GAC | 920 patients with gastric adenocarcinoma Receives: Other: Routine care as per site standard | |
| GEJAC | 580 patients with gastroesophageal junction adenocarcinoma Receives: Other: Routine care as per site standard | |
| EAC | 150 patients with esophageal adenocarcinoma Receives: Other: Routine care as per site standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of treatment (treatment reality)
Documentation of anamnestic data and therapy sequences
Measured: 2 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start4 Dec 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Dechow, Prof., Study chair, RavensburgFlorian Lordick, Prof., Study chair, LeipzigSylvie Lorenzen, Prof., Study chair, MünchenKarin Potthoff, Dr., Study chair, FreiburgAnke Reinacher-Schick, Prof., Study chair, Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290806
- Sponsor's protocol ID
- IOM-090358
- Acronym
- SAPHIR
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2020
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04290806
- Acronym / sponsor ID
- SAPHIR / IOM-090358
- Conditions
- Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Keywords
- neoplasms, registry, health services research, epidemiology, Germany, palliative treatment, palliative care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESCC | – | Other: Routine care as per site standard250 patients with esophageal squamous cell carcinoma |
| GAC | – | Other: Routine care as per site standard920 patients with gastric adenocarcinoma |
| GEJAC | – | Other: Routine care as per site standard580 patients with gastroesophageal junction adenocarcinoma |
| EAC | – | Other: Routine care as per site standard150 patients with esophageal adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Histologically proven stage IV (metastatic) ESCC, EAC, GAC or GEJAC
- Planned palliative systemic first-line therapy
- Age >= 18 years
- Signed informed consent (IC)
Key exclusion criteria (1 listed)
- No systemic therapy for ESCC, EAC, GAC or GEJAC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine care as per site standardPhysician's choice according to patient's needs. Routine care as per site standard. | Other | EAC, ESCC, GAC, GEJAC |
Primary outcome
Course of treatment (treatment reality)
Time frame: 2 years per patient
Documentation of anamnestic data and therapy sequences
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tobias Dechow, Prof. study chair
Ravensburg
Florian Lordick, Prof. study chair
Leipzig
Sylvie Lorenzen, Prof. study chair
München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma and Gastric Adenocarcinoma, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrian Binninger (+49 761 152 42 - 0, info@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of treatment (treatment reality) (time frame: 2 years per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.