About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Heinrich-Heine University, Duesseldorf
Lead sponsor
University Hospital of Cologne
Collaborator