RecruitingNCT04455282

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


Sponsor

Heinrich-Heine University, Duesseldorf

Enrollment

100 participants

Start Date

Feb 1, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how blood markers (circulating biomarkers) in patients with cancer at the junction of the stomach and esophagus can help predict which patients benefit most from surgery after chemotherapy. The goal is to personalize treatment decisions based on each patient's biology. **You may be eligible if:** - You have been diagnosed with a confirmed adenocarcinoma (a specific cancer type) at the junction where the esophagus meets the stomach (GEJ type I or II) - Your cancer has not spread to distant organs and appears surgically removable - You are 18 or older and in reasonable general health - Your cancer is at a stage appropriate for chemotherapy followed by surgery **You may NOT be eligible if:** - Your cancer is a different tumor type (squamous or other non-adenocarcinoma) - Your cancer has spread to distant organs (metastatic) or cannot be surgically removed - Your early-stage cancer (T1N0) has not yet spread to lymph nodes - You have not provided written informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Universitätsklinikum Münster

Münster, North-Rhine Westfalia, Germany

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NCT04455282


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