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

Rennes University Hospital26 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

cN0 Oral Squamous Cell Carcinomas

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre hospitalier universitaire de Rennes

Rennes, France

Outcomes

Primary Outcomes

number of CK19 mRNA copies/µL of diluted lymph node lysate

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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