Status:
RECRUITING
CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
University Hospital of Cologne
Conditions:
Cancer of Esophagus
Esophagogastric Junction Disorder
Eligibility:
All Genders
18+ years
Brief Summary
This is an exploratory observational biomarker study in approximately 100 eligible patients with resectable adenocarcinomas of the esophagus and gastro- esophageal junction (GEJ) type I-II (GEAC) to i...
Detailed Description
This is an exploratory observational biomarker study. Around 20 mL of blood will be collected from a peripheral vein and additional 40 mL from tumor draining veins. In addition, around 5 mL of lymphat...
Eligibility Criteria
Inclusion
- histologically proven adenocarcinoma of the GEJ type I and II, resectable, non-metastatic tumor
- age ≥18
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2,
- American Society of Anesthesiologists (ASA) \< 4.
- pre-treatment stage cT1N+ M0 or cT2-4a N0/N+, M0 GEJ type I and II adenocarcinomas can be included. In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior inclusion.
- Written informed consent and the ability to understand the nature of the study and the study-related procedures and to comply with them has to be ensured.
Exclusion
- tumors of squamous, adenosquamous or other non-adenocarcinoma histology
- patients with inoperable or metastatic GEJ type I and II adenocarcinoma, GEJ type I and II adenocarcinoma staged cT1N0 and cT4b, GEJ type I and II cT4a evaluated as not curatively resectable by the local surgical investigator
- unsigned informed consent
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04455282
Start Date
February 1 2021
End Date
January 30 2028
Last Update
March 8 2024
Active Locations (2)
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1
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany
2
Universitätsklinikum Münster
Münster, North-Rhine Westfalia, Germany, 48149