NCT04455282 CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1
| NCT ID | NCT04455282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heinrich-Heine University, Duesseldorf |
| Condition | Cancer of Esophagus |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-02-01 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. * pre-treatment stage cT1N+ M0 or cT2-4a N0/N+, M0 GEJ type I and II adenocarcinomas can be included. In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior inclusion. * Written informed consent and the ability to understand the nature of the study and the study-related procedures and to comply with them has to be ensured. Exclusion Criteria: * 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
Contact & Investigator
Nikolas Stoecklein, MD
PRINCIPAL INVESTIGATOR
Surgery, University Hospital Düsseldorf Germany
Frequently Asked Questions
Who can join the NCT04455282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer of Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04455282 currently recruiting?
Yes, NCT04455282 is actively recruiting participants. Contact the research team at Nikolas.Stoecklein@med.uni-duesseldorf.de for enrollment information.
Where is the NCT04455282 trial being conducted?
This trial is being conducted at Cologne, Germany, Münster, Germany.
Who is sponsoring the NCT04455282 clinical trial?
NCT04455282 is sponsored by Heinrich-Heine University, Duesseldorf. The principal investigator is Nikolas Stoecklein, MD at Surgery, University Hospital Düsseldorf Germany. The trial plans to enroll 100 participants.
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