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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01074684
First received: February 23, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Phase
Thyroid Cancer
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Defining Predictive Factors of Clinical, Laboratory and Imaging Criteria Routinely Used in the Diagnosis of Thyroid Cancer: Observational, Prospective Multicentered Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • positive predictive value of preoperative suspicious clinical, laboratory and imaging findings [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Enrollment: 959
Study Start Date: January 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074684

Locations
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, Italy
Sponsors and Collaborators
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
Principal Investigator: Massimo Di Maio, M.D. National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D. National Cancer Institute, Naples
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01074684     History of Changes
Other Study ID Numbers: TIR-2009-01
Study First Received: February 23, 2010
Last Updated: July 29, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
diagnosis
nodules
fine needle aspiration

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 22, 2014