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

NCT ID: NCT02852343

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-05
• Study Completion Date: 2016-12-21

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).

Conditions

cN0 Oral Squamous Cell Carcinomas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre hospitalier universitaire de Rennes

Rennes, , France

Countries

France

References

Peigne 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.

Reference Type: DERIVED

PMID: 32004908 (View on PubMed)

Other Identifiers

35RC14_9878

Identifier Type: -

Identifier Source: org_study_id