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

NCT02892786 | Completed

• 1 other identifier: 2010-A00586-33
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Head and Neck Cancer

Keywords

circulating tumor cell; CellSearch™ method; RT-PCR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison between RT-PCR and CellSearch™ method

  1 day

• Prognostic marker of relapse

  2 years

Study Arms (1)

experimental

EXPERIMENTAL

Other: Circulating Tumor Cells

Interventions

Circulating Tumor Cells OTHER

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.

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MASTRONICOLA Romina, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: December 8, 2010
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)