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

NCT ID: NCT03889769

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-20
• Study Completion Date: 2019-09-30

Brief 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.

Detailed Description

Papillary thyroid carcinoma (PTC) is the most common malignant thyroid neoplasm; it originates from follicular cells of thyroid gland, and represents over 80% of thyroid tumors. The incidence of PTC has progressively been increasing in the last decades, doubling since the 1970s, due to the diffusion of screening ultrasound. Although PTCs are considered slow-growing tumors, the incidence of node metastases is high, ranging from 20% to 90%. The real impact of node metastases on prognosis is still a matter of debate: reports in literature demonstrate a reduction of disease-free survival but are divergent on overall survival. Diagnostic tools have poor accuracy for central lymph node compartment, which is the most frequent site of metastases.

The last guidelines suggest a prophylactic central lymph node compartment dissection (CLND) in patients with high-risk PTC; nevertheless, this indication meets resistance due to the higher incidence of postoperative complications, especially hypoparathyroidism and recurrent laryngeal nerve (RLN) palsy.

Recently, new molecular biologic techniques have spread widely, mainly in diagnosis of node metastases in breast carcinoma; these assays allow to quickly isolate, amplify and quantify mRNA encoding for proteins selectively present in neoplastic cells, as Cytokeratine-19 (CK-19). One Step Nucleic Acid Amplification (OSNA) is routinely used in diagnosis of node metastasis in sentinel lymph node (SNL) of patients affected from breast cancer. The aim of this study is to evaluate if application of OSNA to intraoperative diagnosis of node metastases of PTC is possible.

Conditions

Papillary Thyroid Cancer; Lymph Node Metastases

Study Design

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

Interventions

OSNA test

Analysis of lymph node with OSNA

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Preoperative diagnosis of thyroid carcinoma

Exclusion Criteria

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Fabio Medas

Research fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pietro Giorgio Calò

Role: PRINCIPAL_INVESTIGATOR

University of Cagliari

Locations

Policlinico di Monserrato

Monserrato, Cagliari, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabio Medas

Role: CONTACT

fabiomedas@gmail.com

+393206836288

Fabio Medas

Role: CONTACT

fabiomedas@unica.it

+3951096288

Facility Contacts

Fabio Medas

Role: primary

fabiomedas@gmail.com

+393206836288

Other Identifiers

NP20164594

Identifier Type: -

Identifier Source: org_study_id