Clinical trial · Interventional
Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC
Resectable Esophageal Adenocarcinoma: The Influence of Multimodal Therapy on the Prevalence and Enumeration of Circulating Tumor Cells in Comparison With Conventional Response Evaluation in a Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the feasibility of evaluation of prevalence and clinical significance and relevance of circulating tumor cells (CTC) in the blood of patients with resectable adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. The primary hypothesis is that the number of CTC correlates with tumor burden and response to treatment. One established and one experimental CTC detection platform will be investigated. Investigators will evaluate the prevalence and enumeration of CTC before neoadjuvant treatment (time point 1), after neoadjuvant treatment \& before operation (time point 2) and after the operation (time point 3). Results will be compared with healthy controls (one time point) and correlated with conventional response to treatment evaluation. The persistent presence of CTC could be a marker for worse response to treatment and predict early recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Test for CTC evaluation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental diagnostic test
- description
- Evaluation and enumeration of circulating Tumor cells from the blood with two different CTC-detection platforms: one established test (CellSearch) and one experimental test (ScreenCell). Control diagnostic test: CT-Scan of the Chest and the Abdomen, Endoscopy and Endosonography, Clinical response and histo pathologic response. (% Of vital tumor Cells in the histologic specimen).
- interventionNames
- Procedure: Blood Test for CTC evaluation
Primary outcomes (1)
- measure
- Change of numbers of CTCs in patients with resectable EAC at diagnosis, after neoadjuvant treatment and after surgery.
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Number of patients with detectable CTCs at diagnosis, after neoadjuvant treatment and after surgery.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified adenocarcinoma of the esophagus According to the UICC definition (TNM7), * pre-treatment stage cT1N+, M0 or cT2-4aN0/N+, M0 , * Age≥18 years, * scheduled for a multimodal therapeutic concept. Exclusion Criteria: * Tumors of squamous, adenosquamous or other non-adenocarcinoma histology, patients with advanced inoperable or metastatic esophageal adenocarcinoma. * Esophageal adenocarcinoma cT1N0 and cT4b, * Gastric carcinoma. * Prior chemotherapy for gastrointestinal cancer. Clinically not eligible for surgery
References
Publications (0)
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