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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: Circulating Tumor Cells

• Registration Number: NCT02892786
• Lead Sponsor: Institut de Cancérologie de Lorraine

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-08
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-08
• Primary Completion: 2017-12
• Study Completion: 2018-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental	Circulating Tumor Cells	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-les-Nancy, France