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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Circulating Tumor Cells
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Head and Neck Cancer focused on measuring circulating tumor cell, CellSearch™ method, RT-PCR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut de Cancérologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental

Arm Description

Outcomes

Primary Outcome Measures

Circulating tumor cells in peripheral blood during head and neck surgery
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.

Secondary Outcome Measures

Comparison between RT-PCR and CellSearch™ method
The comparison between RT-PCR and CellSearch™ method will be the positivity sample rate
Prognostic marker of relapse
Local recurrence, regional or metastatic head and neck cancer in the two years

Full Information

First Posted
September 2, 2016
Last Updated
August 7, 2018
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT02892786
Brief Title
Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma
Acronym
CTCVADS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 8, 2010 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
circulating tumor cell, CellSearch™ method, RT-PCR

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Circulating Tumor Cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Circulating tumor cells in peripheral blood during head and neck surgery
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Comparison between RT-PCR and CellSearch™ method
Description
The comparison between RT-PCR and CellSearch™ method will be the positivity sample rate
Time Frame
1 day
Title
Prognostic marker of relapse
Description
Local recurrence, regional or metastatic head and neck cancer in the two years
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MASTRONICOLA Romina, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de Lorraine
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54519
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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