Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT01858805
• Collaborator: (none)
• Enrollment: 123
• Location: 1
• Duration (Months): 48
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

Despite the availability of several preoperative diagnostic techniques, accurate pretreatment staging of esophageal cancer (EC) remains challenging. Therefore, The investigators evaluated the prognostic significance of circulating tumor cells (CTCs) in patients with EC.

Condition or Disease	Intervention/Treatment	Phase
Resectable Esophageal Cancer	Procedure: esophagectomy

Study Design

• Study Type: Observational
• Actual Enrollment: 123 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
detection of circulating tumors cells This prospective, single-institution study conducted at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) enrolled 123 patients with ECs that were initially considered resectable. Only patients with histologically proven EC were included. Peripheral blood samples for CTC analysis were collected immediately before surgery.	Procedure: esophagectomy

Outcome Measures

Primary Outcome Measures

1. overall survival [2 years]

Secondary Outcome Measures

1. recurrence-free survival [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years

• resectable esophageal cancer

Exclusion Criteria:

• < 18 years

• esophageal cancer with preoperative distant metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. med. Matthias Reeh, MD, Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT01858805
• Other Study ID Numbers: CTC-EC; 184
• First Posted: May 21, 2013
• Last Update Posted: Nov 18, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Dr. med. Matthias Reeh, MD, Universitätsklinikum Hamburg-Eppendorf: esophagus carcinoma; surgery; circulating tumor cells
• Additional relevant MeSH terms: Esophageal Neoplasms; Neoplastic Cells, Circulating

Study Results

No Results Posted as of Nov 18, 2014