Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma (CTCVADS)

August 7, 2018 updated by: Institut de Cancérologie de Lorraine

The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance.

The objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-les-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient with head and neck squamous cell cancer stage III or IV histologically proven
  • Patient naive to any prior therapy
  • Patient with operate cancer and resectable tumor
  • Hemoglobin ≥ 10g / dL
  • Performance status ≤ 2
  • Ability to provide written informed consent
  • Patient's legal capacity to consent to study participation

Exclusion Criteria:

  • Other previous histology tumors
  • Medical conditions or acute or chronic severe psychiatric disorders
  • Deprived of liberty or under supervision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
Other: Circulating Tumor Cells

Patients with stage III and IV head and neck squamous cell carcinoma undergoing surgery were enrolled in this study

5 and 7.5 ml of peripheral venous blood will be taken before the surgery, just at the end of surgery and one week after surgery

Analysis was performed by RT-PCR and the CellSearch™ method using immunomagnetic and fluorescence approaches.

Patients will be followed every 3 months for two years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating tumor cells in peripheral blood during head and neck surgery
Time Frame: 7 days
The number of circulating tumor cells detected per milliliter of peripheral blood will be evaluated on the day before, the day of surgery and 7 days after the surgery.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between RT-PCR and CellSearch™ method
Time Frame: 1 day
The comparison between RT-PCR and CellSearch™ method will be the positivity sample rate
1 day
Prognostic marker of relapse
Time Frame: 2 years
Local recurrence, regional or metastatic head and neck cancer in the two years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: MASTRONICOLA Romina, MD, Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2010

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

September 2, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A00586-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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