NCT00571090

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
735

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

9.1 years

First QC Date

December 10, 2007

Last Update Submit

March 28, 2014

Conditions

Thyroid Nodule

Keywords

Thyroid noduleBiopsy, Fine-Needle

Outcome Measures

Primary Outcomes (1)

  • Thyroid cancer

    one year

Study Arms (1)

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

Interventions

Thyroid ultrasonographyPROCEDURE

Ultrasound-guided thyroid fine-needle aspiration biopsy

Thyroid nodule

Eligibility Criteria

Age15 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Endocrinology Clinic

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Florence Nightingale

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Can AS. Cost-effectiveness comparison between palpation- and ultrasound-guided thyroid fine-needle aspiration biopsies. BMC Endocr Disord. 2009 May 16;9:14. doi: 10.1186/1472-6823-9-14.

    PMID: 19445710BACKGROUND

Related Links

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Ahmet Selcuk Can, MD

    Istanbul Science University and Group Florence Nightingale

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 11, 2007

Study Start

June 1, 2003

Primary Completion

July 1, 2012

Study Completion

July 1, 2013

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

TU(1)