NCT01858805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

4 years

First QC Date

May 14, 2013

Last Update Submit

November 17, 2014

Conditions

Resectable Esophageal Cancer

Keywords

esophagus carcinomasurgerycirculating tumor cells

Outcome Measures

Primary Outcomes (1)

  • overall survival

    2 years

Secondary Outcomes (1)

  • recurrence-free survival

    2 years

Study Arms (1)

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

Interventions

esophagectomyPROCEDURE
detection of circulating tumors cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This prospective, single-institution study conducted at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) enrolled 123 patients with ECs that were initially considered resectable.

You may qualify if:

  • \> 18 years
  • resectable esophageal cancer

You may not qualify if:

  • \< 18 years
  • esophageal cancer with preoperative distant metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Esophageal NeoplasmsNeoplastic Cells, Circulating

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 21, 2013

Study Start

April 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

DE(1)