Predictive Factors of Clinical, Laboratory and Imaging Findings Routinely Used in Diagnosing Thyroid Cancer (TIR-2009-01)

March 23, 2023 updated by: National Cancer Institute, Naples

Defining Predictive Factors of Clinical, Laboratory and Imaging Criteria Routinely Used in the Diagnosis of Thyroid Cancer: Observational, Prospective Multicentered Study

The purpose of this study is to describe the correlation between the cytohistology exam of patients undergoing thyroid surgery, and the predictive values of: suspicious clinical findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically negative nodes.

Study Overview

Status

Completed

Conditions

Thyroid Cancer

Study Type

Observational

Enrollment (Actual)

959

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
- - Cagliari, Italy
    - Università di Cagliari
  - Firenze, Italy
    - Azienda Ospedaliera Unviersitaria Careggi - Firenze
  - Ivrea, Italy
    - ASL TO/4 Ospedale di Ivrea
  - Napoli, Italy
    - Istituto Nazionale Dei Tumori
  - Padova, Italy
    - Azienda Ospedaliera Universitaria di Padova
  - Roma, Italy
    - Università Cattolica del Sacro Cuore di Roma Policlinico Gemelli
  - Taormina, Italy
    - Ospedale di Taormina
  - Terni, Italy
    - Università degli studi di Perugia - Sede di Terni

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with palpable thyroid nodules with indication for surgery (positive cytology, 2 consecutive inconclusive cytologies, or negative cytology with at least 2 of the following: previous exposure to neck radiation, calcitonin greater than twice normal values, positive pentagastrin test, or irregular margins or hypoechogenicity on ultrasound.

Description

Inclusion Criteria:

Consecutive patients presenting for thyroid disease (palpable nodules)
Indication for surgery
Age > 18 years
Signed informed consent for surgery
Signed informed consent for data collection

Exclusion Criteria:

Concurrent condition that contraindicates surgery
Clinical or radiologic evidence of locally advanced tumor
Clinical or radiologic evidence of metastatic lymph nodes or distant metastases
Nonpalpable nodes

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
positive predictive value of preoperative suspicious clinical, laboratory and imaging findings Time Frame: at baseline	at baseline

Collaborators and Investigators

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

Sponsor

National Cancer Institute, Naples

Investigators

Principal Investigator: Luciano Pezzulo, M.D., National Cancer Institute, Naples
Principal Investigator: Maria Grazia Chiofalo, M.D., National Cancer Institute, Naples

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

January 1, 2010

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria