Predictive Factors of Clinical, Laboratory and Imaging Findings Routinely Used in Diagnosing Thyroid Cancer

Thyroid Cancer Clinical Trial

— TIR-2009-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074684
• Other study ID #: TIR-2009-01
• Status: Completed
• Start date: January 2010
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 959
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Italy	Università di Cagliari	Cagliari
Italy	Azienda Ospedaliera Unviersitaria Careggi - Firenze	Firenze
Italy	ASL TO/4 Ospedale di Ivrea	Ivrea
Italy	Istituto Nazionale dei Tumori	Napoli
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive predictive value of preoperative suspicious clinical, laboratory and imaging findings		at baseline