UNN-RADS Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer

November 6, 2023 updated by: Hilda Elizabeth Macías Cervantes, Instituto Mexicano del Seguro Social

Validation of The Ultrasound Neck Node Reporting and Data System (UNN-RADS) Scale for Diagnosing Lymph Node Metastasis in Patients With History of Thyroid Cancer

In 2020, Sarda-Inman et al., developed the Ultrasound Neck Node Reporting and Data System (UNN-RADS) scale that allows decision-making about when it is appropriate to perform FNA of a cervical lymph node, evaluating seven ultrasonographic descriptors (shape, margins, echogenicity, echogenicity of the hilum, vascularity and the presence/absence of calcifications, and cystic degeneration), features that have been associated with metastatic lymph nodes, with scores ranging from 0 to 3 points, which allows categorize into 5 different risk groups. Thus, the objective of this study is to evaluate the ultrasound characteristics of metastatic LN in patients undergoing TC follow-up and to validate the UNN-RADS scale for the diagnosis of LN Metastasis in Patients with a history of TC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study enrolled consecutive patients in follow-up for differentiated thyroid cancer (DTC) history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes. Patients were included if they 1) had previous history of DTC, 2) both sexes with age over 18 years old, and 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1. Patients were excluded if they underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer, had previous bilateral cervical lymph node dissection as initial treatment, or the FNA results were not concluded.

UNN-RADS 1 y 2 and UNN-RADS 3, 4 and 5 were grouped for analysis purpose. Diagnostic performance of UNN-RADS scale were assessed in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), positive likelihood ratios (+LR), negative likelihood ratios (-LR) and accuracy, as well as with a receiver operating characteristic (ROC) curve.

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37260,
        • Unidad Medica de Alta Especialidad No. 1, Bajío

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical lymph nodes at Unidad Médica de Alta Especialidad HE 1 CMN Bajío

Description

Inclusion Criteria:

  • 1) had previous history of DTC 2) both sexes with age over 18 years old 3) underwent FNA of the LNs for any suspected features corresponding with at least UNN-RADS 1

Exclusion Criteria:

  • 1) underwent FNA of the LNs for persistent or recurrent disease after surgery for thyroid cancer 2) had previous bilateral cervical lymph node dissection as initial treatment 3) FNA results were not concluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benign lymph nodes
Categories UNN-RADS 1 and 2 (test negative)
Diagnostic test: US-guided fine needle aspiration (FNA)
This study enrolled consecutive patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical
Metastatic lymph nodes
Categories UNN-RADS 3, 4, and 5 (test positive).
Diagnostic test: US-guided fine needle aspiration (FNA)
This study enrolled consecutive patients in follow-up for DTC history who underwent US-guided fine needle aspiration (FNA) of the LNs for suspicious metastatic cervical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metastatic lymph node
Time Frame: All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.
Fine needle aspiration biopsy (FNA) results were the gold standard (metastatic or benign).
All biopsy samples were sent to the pathology department of the unit, where final results were obtained in approximately 2-3 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Study Chair: Hilda Maciaqs, PhD, Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

October 23, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated or analyzed during the study are available from the principal investigator on reasonable request.

IPD Sharing Time Frame

1 month

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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