Detection in Peripheral Blood of Circulating Tumor Cells in Patient With Head and Neck Squamous Cell Carcinoma (CTCVADS)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vandœuvre-lès-Nancy, France, 54519
- Institut de Cancerologie de Lorraine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
|
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.
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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
Investigators
- Principal Investigator: MASTRONICOLA Romina, MD, Institut de Cancerologie de Lorraine
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-A00586-33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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