Clinical trial · Observational
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
NCT02852343CI-TRIAL-00034798OSNA-ORLcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| cN0 Oral Squamous Cell Carcinomas | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- number of CK19 mRNA copies/µL of diluted lymph node lysate
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPeigne L, Godey F, Le Gallo M, Le Gall F, Fautrel A, Morcet J, Jegoux F. One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma. Oral Oncol. 2020 Mar;102:104553. doi: 10.1016/j.oraloncology.2019.104553. Epub 2020 Jan 28. PMID 32004908