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Evaluation of Accuracy of One-Step Nucleic Acid Amplification (OSNA) in Diagnosis of Lymph Node Metastases of Papillary Thyroid Carcinoma

NCT03889769 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-03-26

No results posted yet for this study

Summary

The incidence of node metastases in papillary thyroid carcinoma (PTC) is high, ranging from 20% to 90%. Prophylactic central lymph node compartment dissection (CLND), suggested from the latest guidelines for high-risk tumors, meets resistance due to the high incidence of postoperative complications. Recently, new molecular biologic techniques, such as One Step Nucleic Acid Amplification (OSNA), have spread widely, allowing to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19. The aim of this study is to evaluate the application of OSNA to intraoperative diagnosis of node metastases of PTC.

Conditions

  • Papillary Thyroid Cancer
  • Lymph Node Metastases

Interventions

DIAGNOSTIC_TEST

OSNA test

Analysis of lymph node with OSNA

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Principal Investigators

  • Pietro Giorgio Calò · University of Cagliari

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2019-04-01
Completion
2019-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03889769 on ClinicalTrials.gov