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

Rennes University Hospital

Status: Completed

Conditions: cN0 Oral Squamous Cell Carcinomas

Study type: Observational

Funder types: Other

Identifiers

NCT02852343

35RC14_9878

Details and patient eligibility

About

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).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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