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Age: 18Years +
All Genders
ID04455282
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
160 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
Researchers are exploring the use of blood-based biomarkers to improve the surgical treatment of patients with resectable adenocarcinomas of the esophagus and gastro-esophageal junction types I and II. This observational study aims to compare the frequency of circulating tumor cells (CTCs) in blood from peripheral veins versus tumor-draining veins, and to assess the prognostic value of additional biomarkers. The goal is to enhance preoperative staging and better identify patients at risk for metastasis, which could lead to more tailored treatment plans including neoadjuvant, peri-operative, or surgical approaches alone. The study involves collecting around 20 mL of blood from a peripheral vein and 40 mL from tumor-draining veins during surgery. Additionally, about 5 mL of lymphatic fluid will be collected from the thoracic duct if accessible. Blood samples will then be analyzed for CTCs, tumor-derived extracellular vesicles (tdEVs), and circulating tumor DNA (ctDNA) using specialized laboratory techniques. Resected tissue not needed for routine pathology will be stored in a biobank for future research. After surgery, annual blood samples will be taken during routine follow-up or at relapse. Participants will undergo blood and lymphatic fluid collection during surgery, with follow-up blood draws for up to five years. Researchers will measure the difference in CTC detection rates between blood sources over 24 months, assess other biomarkers, and correlate findings with clinical outcomes over seven years. Safety monitoring includes ensuring patients meet performance status and surgical fitness criteria. This long-term follow-up helps evaluate how the biomarkers relate to disease progression and treatment outcomes.
CONDITIONS
Brief Title
CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically proven adenocarcinoma of the gastro-esophageal junction (GEJ) type I or II, resectable and non-metastatic
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- American Society of Anesthesiologists (ASA) physical status less than 4
- Pre-treatment stage cT1N+ M0 or cT2-4a N0/N+, M0 GEJ type I and II adenocarcinomas
- For stage cT4a, curative resectability must be confirmed by the local surgical investigator
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- Tumors with 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 tumors evaluated as not curatively resectable by the local surgical investigator
- Lack of signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
During surgery, blood and lymphatic fluid samples are collected. Tissue not needed for routine pathology is also collected for biobanking.
1 visit (in-person, during surgery)
Long-term Monitoring
Duration - Up to 84 months
Participants have annual blood draws during routine clinical follow-up or at relapse to collect biomarkers for analysis.
Annual visits for blood draws
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
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Research Team
N
Nikolas H Stoecklein, MD
C
Christiane Bruns, MD
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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