Observational Recruiting
NCT04455282 on ClinicalTrials.gov
CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1
- Sponsor: Heinrich Heine University Düsseldorf
- Collaborators: University Hospital of Cologne
- Enrollment: 100 (Estimated)
- Study start: 2021-02-01 (Actual)
- Primary completion: 2024-12-30 (Estimated)
- Study completion: 2028-01-30 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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 investigate the difference deletion frequency of circulating tumor cells (CTCs) between peripheral veins and tumor-draining veins (primary endpoint), prognostic value, relevance of a set of two additional blood-based biomarkers analyzed from a single blood sampling tube (secondary endpoints). The underlying hypothesis is that the biomarker alone or in combination improve preoperative staging and help to identify patients at risk for metastasis. This should enable a better stratification of GEAC patients to neo-adjuvant treatment, (intensified) peri-operative treatment, or even surgery alone, in selected cases. The data of the CIRCULATE study shall be used design subsequent studies testing the predictive role of these biomarkers for surgical management. Patients will provide blood samples and lymphatic fluid during the operation and annual blood samples during clinical follow up of 5 years.
Conditions
- Cancer of Esophagus
- Esophagogastric Junction Disorder
Primary Outcome Measures
-
Difference in CTC detection rate between peripheral and tumor draining veins.
(24 months)
The difference between the CTC positivity rate (≥1 CTC / 7.5 mL) in blood samples of tumor-draining veins compared to the CTC positivity rate in peripheral blood. The positivity fraction and CTC number per 7.5 mL in tumor draining veins and peripheral blood samples will be determined by CellSearch.
Countries
Germany
Locations and Investigators
-
Universitätsklinikum Münster, Münster, Germany (Not yet recruiting)
- Mazen A Juratli, MD, PhD
-
University Hospital Cologne, Cologne, Germany (Recruiting)
- Christiane Bruns, MD
- Raphael Stier, MD
Study Officials
- Nikolas Stoecklein, MD (Principal Investigator) — Surgery, University Hospital Düsseldorf Germany
- Christiane Bruns, MD (Principal Investigator) — Surgery, University Hospital Cologne