Predictive Factors of Clinical, Laboratory and Imaging Findings Routinely Used in Diagnosing Thyroid Cancer
TIR-2009-01
Defining Predictive Factors of Clinical, Laboratory and Imaging Criteria Routinely Used in the Diagnosis of Thyroid Cancer: Observational, Prospective Multicentered Study
1 other identifier
observational
959
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 23, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 24, 2023
March 1, 2023
11.9 years
February 23, 2010
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
positive predictive value of preoperative suspicious clinical, laboratory and imaging findings
at baseline
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Università di Cagliari
Cagliari, Italy
Azienda Ospedaliera Unviersitaria Careggi - Firenze
Florence, Italy
ASL TO/4 Ospedale di Ivrea
Ivrea, Italy
Istituto Nazionale dei Tumori
Napoli, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, Italy
Università Cattolica del Sacro Cuore di Roma Policlinico Gemelli
Roma, Italy
Ospedale di Taormina
Taormina, Italy
Università degli studi di Perugia - Sede di Terni
Terni, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luciano Pezzulo, M.D.
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
Maria Grazia Chiofalo, M.D.
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
Massimo Di Maio, M.D.
National Cancer Institute, Naples
- PRINCIPAL INVESTIGATOR
Francesco Perrone, M.D., Ph.D.
National Cancer Institute, Naples
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2010
First Posted
February 24, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
March 24, 2023
Record last verified: 2023-03