Actively Recruiting
CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1
Led by Heinrich-Heine University, Duesseldorf · Updated on 2024-03-08
100
Participants Needed
2
Research Sites
364 weeks
Total Duration
On this page
Sponsors
H
Heinrich-Heine University, Duesseldorf
Lead Sponsor
U
University Hospital of Cologne
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven resectable adenocarcinoma of the gastro-esophageal junction (GEJ) type I or II, non-metastatic tumor
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- American Society of Anesthesiologists (ASA) score less than 4
- Pre-treatment stage cT1N+ M0 or cT2-4a N0/N+ M0 GEJ type I and II adenocarcinomas; for cT4a, curative resectability must be confirmed by the local surgical investigator
- Written informed consent and ability to understand and comply with the study procedures
You will not qualify if you...
- 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
- cT4a tumors evaluated as not curatively resectable by the local surgical investigator
- Lack of signed informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany
Actively Recruiting
2
Universitätsklinikum Münster
Münster, North-Rhine Westfalia, Germany, 48149
Not Yet Recruiting
Research Team
N
Nikolas H Stoecklein, MD
CONTACT
C
Christiane Bruns, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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