Prediction of Thyroid Cancer From Ultrasonographic Characteristics of Thyroid Nodules

This study has been completed.
Sponsor:
Collaborator:
Group Florence Nightingale
Information provided by (Responsible Party):
Ahmet Selcuk Can, Istanbul Science University
ClinicalTrials.gov Identifier:
NCT00571090
First received: December 10, 2007
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The aim of this study is to identify which ultrasonographic feature or a combination of features is the best predictor of thyroid cancer in thyroid nodules.


Condition Intervention
Thyroid Nodule
Procedure: Thyroid ultrasonography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of Thyroid Fine Needle Aspiration Biopsies: Prediction of Thyroid Cancer From Ultrasonographic Characteristics of Thyroid Nodules

Resource links provided by NLM:


Further study details as provided by Istanbul Science University:

Primary Outcome Measures:
  • Thyroid cancer [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 735
Study Start Date: June 2003
Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thyroid nodule
Subjects who present with thyroid nodules will be enrolled into the study. Euthyroid and hypothyroid subjects with a solitary thyroid nodule or multinodular goiter will be enrolled. For subjects with a suppressed TSH, a thyroid scan will be performed. Subjects with a hypoactive nodule in the thyroid scan and a low TSH will be enrolled.
Procedure: Thyroid ultrasonography
Ultrasound-guided thyroid fine-needle aspiration biopsy

  Eligibility

Ages Eligible for Study:   15 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Endocrinology Clinic

Criteria

Inclusion Criteria:

  • Subjects with thyroid nodules over 10 mm in the longest diameter
  • Euthyroid or hypothyroid subjects with a solitary thyroid nodule or multinodular goiter
  • Subjects with a hypoactive nodule in the thyroid scan and a low TSH

Exclusion Criteria:

  • Subjects with four or more thyroid nodules that are over 10 mm
  • Subjects with low TSH and hyperactive nodule on thyroid scan
  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: NCT00571090

Locations
Turkey
Group Florence Nightingale
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Science University
Group Florence Nightingale
Investigators
Principal Investigator: Ahmet Selcuk Can, MD Istanbul Science University and Group Florence Nightingale
  More Information

Additional Information:
Publications:
Responsible Party: Ahmet Selcuk Can, Associate Professor of Medicine, Istanbul Science University
ClinicalTrials.gov Identifier: NCT00571090     History of Changes
Other Study ID Numbers: B.30.2.IBU.0.01.00.00/511, 511
Study First Received: December 10, 2007
Last Updated: March 28, 2014
Health Authority: Turkey: Ministry of Health

Keywords provided by Istanbul Science University:
Thyroid nodule
Biopsy, Fine-Needle

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

ClinicalTrials.gov processed this record on September 18, 2014