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

Etude de Concordance Entre la Technique OSNA et Les Techniques Classiques Pour la Recherche de métastases Ganglionnaires Des Cancers Des VADS

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02852343

Acronym

OSNA-ORL

Enrollment

Registered

2016-08-02

Start date

2015-01-05

Completion date

2016-12-21

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cN0 Oral Squamous Cell Carcinomas

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

France

Outcome results