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OpenTrials
Completed

NCT Number: NCT02852343

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

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).

Completed

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Key information

Conditions

cN0 Oral Squamous Cell Carcinomas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire de Rennes

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: OSNA-ORL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2016
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.