Exploring biomarkers for personalized treatment in esophageal cancer
CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1
Heinrich-Heine University, Duesseldorf · NCT04455282
This study is testing if certain blood markers can help doctors better understand and treat patients with esophageal cancer before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf (other) |
| Locations | 2 sites (Cologne, North Rhine-Westphalia and 1 other locations) |
| Trial ID | NCT04455282 on ClinicalTrials.gov |
What this trial studies
This observational biomarker study aims to analyze circulating tumor cells (CTCs) and other blood-based biomarkers in approximately 100 patients with resectable adenocarcinomas of the esophagus and gastro-esophageal junction. Blood samples will be collected from both peripheral and tumor-draining veins to assess the prognostic value of these biomarkers. The study seeks to improve preoperative staging and identify patients at risk for metastasis, potentially leading to better treatment stratification. Data collected will inform future studies on the predictive role of these biomarkers in surgical management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically proven, resectable adenocarcinomas of the gastro-esophageal junction.
Not a fit: Patients with non-adenocarcinoma histology or those with inoperable or metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for patients with esophageal cancer, improving outcomes.
How similar studies have performed: Other studies have shown promise in using circulating biomarkers for cancer management, but this specific approach is exploratory and novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cologne, North Rhine-Westphalia and 1 other locations
- University Hospital Cologne — Cologne, North Rhine-Westphalia, Germany (RECRUITING)
- Universitätsklinikum Münster — Münster, North-Rhine Westfalia, Germany (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Nikolas Stoecklein, MD — Surgery, University Hospital Düsseldorf Germany
- Study coordinator: Nikolas H Stoecklein, MD
- Email: Nikolas.Stoecklein@med.uni-duesseldorf.de
- Phone: 004921181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer of Esophagus, Esophagogastric Junction Disorder, Circulating Biomarkers, CTC, tdEVs, ctDNA