Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC

NCT02610764 | Completed

• 1 other identifier: ESO-CTC (Pilot)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Esophageal Adenocarcinoma

Keywords

Circulating Tumor Cells; Response evaluation

Outcome Measures

Primary Outcomes (1)

• Change of numbers of CTCs in patients with resectable EAC at diagnosis, after neoadjuvant treatment and after surgery.

  1 year

Secondary Outcomes (1)

• Number of patients with detectable CTCs at diagnosis, after neoadjuvant treatment and after surgery.

  1 year

Other Outcomes (2)

• Overall survival

  2 years after recruitment of last patient

• Progression free survival

  2 years after recruitment of last patient

Study Arms (1)

Experimental diagnostic test

EXPERIMENTAL

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).

Procedure: Blood Test for CTC evaluation

Interventions

Blood Test for CTC evaluation PROCEDURE

Experimental diagnostic test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University of Freiburg - Medical Center

Freiburg im Breisgau, Baden-Würtemberg, 79106, Germany

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Neoplastic Cells, Circulating

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Birte Kulemann, Dr. med.

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Surgery

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

DE (1)