This trial is active, not recruiting.

Condition thyroid cancer
Phase phase 3
Sponsor National Cancer Institute, Naples
Start date January 2010
End date June 2016
Trial size 959 participants
Trial identifier NCT01074684, TIR-2009-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

positive predictive value of preoperative suspicious clinical, laboratory and imaging findings
time frame: at baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Defining Predictive Factors of Clinical, Laboratory and Imaging Criteria Routinely Used in the Diagnosis of Thyroid Cancer: Observational, Prospective Multicentered Study
Principal investigator Luciano Pezzulo, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute, Naples.