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

• Sponsor: Institut de Cancérologie de Lorraine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02892786
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 87.8
• Patients Per Site Per Month: 0.5

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: Circulating Tumor Cells	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Actual Study Start Date: Dec 8, 2010
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: experimental

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Comparison between RT-PCR and CellSearch™ method [1 day]

   The comparison between RT-PCR and CellSearch™ method will be the positivity sample rate

2. Prognostic marker of relapse [2 years]

   Local recurrence, regional or metastatic head and neck cancer in the two years

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cancérologie de Lorraine	Vandoeuvre-les-Nancy		France	54519

Sponsors and Collaborators

• Institut de Cancérologie de Lorraine

Investigators

• Principal Investigator: MASTRONICOLA Romina, MD, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut de Cancérologie de Lorraine
• ClinicalTrials.gov Identifier: NCT02892786
• Other Study ID Numbers: 2010-A00586-33
• First Posted: Sep 8, 2016
• Last Update Posted: Aug 8, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Institut de Cancérologie de Lorraine: circulating tumor cell; CellSearch™ method; RT-PCR
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Aug 8, 2018