Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid

February 15, 2020 updated by: Fabio Medas, University of Cagliari
Papillary thyroid microcarcinoma (PTMC), defined as a tumor with larger diameter ≤ 1 cm, is considered a tumor with an indolent course and an excellent prognosis. Nevertheless, the incidence of lymph node metastasis in PTMC is not negligible, reaching up to 65% in some series. The aim of this study was to assess the incidence of lymph node metastasis in patients with PTMC and to evaluate predictive factors for lymph node metastasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

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

  • Italy
    • CA
      • Cagliari, CA, Italy, 09100
        • AOU Cagliari

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
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with papillary thyroid carcinoma

Description

Inclusion Criteria:

Patients with papillary microcarcinoma of the thyroid

Exclusion Criteria:

Patients with thyroid nodules > 1 cm; incomplete data

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
PTMC
Patients with papillary microcarcinoma of the thyroid
Procedure: Thyroidecomt and lymphectomy
Patients underwent total thyroidectomy or lobectomy associated to lymph node sampling or neck lymphectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of lymph node metastasis
Time Frame: 1 year
To define the incidence of lymph node metastasis in patients with papillary microcarcinoma
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicrive factors of lymph node metastasis
Time Frame: 1 year
To assesss predictive factors of lymph node metastasis
1 year

Collaborators and Investigators

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

Sponsor

University of Cagliari

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)

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

February 15, 2020

First Submitted That Met QC Criteria

February 15, 2020

First Posted (ACTUAL)

February 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICRO-PTC-LN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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