One-step Nucleic Acid Amplification for Detecting Lymph Node Metastasis of Head and Neck Squamous Cell Carcinoma

Completed

• Conditions: cN0 Oral Squamous Cell Carcinomas

• Registration Number: NCT02852343
• Lead Sponsor: Rennes University Hospital

Brief Summary

The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-05
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2016-12-21
• Study Completion: 2016-12-21
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patient > 18 years old
• Head and neck squamous cell carcinoma diagnosed by biopsy
• N0 classification (N0: no lymph node invasion on clinical and radiological examination).
• Neck dissection or sentinel lymph node biopsy required to treat the patient
• ECOG 1,2 or 3
• Patient's consent

Exclusion Criteria

• Patient previously treated by radiotherapy or surgery for head and neck neoplasm.
• Contraindication or patient unwillingness to undergo surgical treatment
• Incapacitated adults

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of CK19 mRNA copies/µL of diluted lymph node lysate	through study completion, an average of 1 year

Trial Locations

Locations (1)

Centre hospitalier universitaire de Rennes; 🇫🇷 Rennes, France