Phase 1 Study of Circulating Biomarkers to Improve Surgical Treatment in Resectable Gastroesophageal Adenocarcinoma

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.

CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1