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

Head and Neck Cancer Clinical Trial

— CTCVADS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892786
• Other study ID #: 2010-A00586-33
• Status: Completed
• Phase: N/A
• Start date: December 8, 2010
• Est. completion date: April 2018

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Neoplastic Cells, Circulating

Intervention

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.

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	Comparison between RT-PCR and CellSearch™ method	The comparison between RT-PCR and CellSearch™ method will be the positivity sample rate	1 day
Secondary	Prognostic marker of relapse	Local recurrence, regional or metastatic head and neck cancer in the two years	2 years