cN0 Oral Squamous Cell Carcinomas Clinical Trial
— OSNA-ORLOfficial title:
Etude de Concordance Entre la Technique OSNA et Les Techniques Classiques Pour la Recherche de métastases Ganglionnaires Des Cancers Des VADS
| Verified date | September 2018 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | December 21, 2016 |
| Est. primary completion date | December 21, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre hospitalier universitaire de Rennes | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | number of CK19 mRNA copies/µL of diluted lymph node lysate | through study completion, an average of 1 year |