Improved Preoperative Selection of Cold Thyroid Nodules

This study is not yet open for participant recruitment.

Verified by Herlev Hospital, October 2007

First Received: February 27, 2006 Last Updated: October 1, 2007 History of Changes

Sponsored by:	Herlev Hospital
Information provided by:	Herlev Hospital
ClinicalTrials.gov Identifier:	NCT00297297

Purpose

Molecular gene profiling of fine-needle aspiration samples in addition to fine-needle aspiration cytology can improve the selection of patients with benign versus malignant thyroid nodules with improved sensitivity.

Condition	Intervention	Phase
Thyroid Nodules	Behavioral: No intervention. Applying gene profiling on needle aspirates	Phase III

Drug Information available for: Thyroid

U.S. FDA Resources

Study Type:	Observational
Study Design:	Longitudinal, Defined Population, Prospective Study
Official Title:	Preoperative Selection of Solitary Solid Cold Thyroid Nodules - A Prospective Study on the Value of Sonography, Cytology, Immunostaining and Molecular Profiling

Further study details as provided by Herlev Hospital:

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2011

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Solitary thyroid nodules that appear solid on ultrasound and cold on a scintiscan

Exclusion Criteria:

Pregnancy and lactation
Age below 20 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297297

Locations

Denmark
Outpatient clinic of The Department of Endocrinology, Herlev University Hospital
Copenhagen, Denmark, 2730

Sponsors and Collaborators

Herlev Hospital

Investigators

Principal Investigator:

Finn N Bennedbaek, MD, PhD

Department of Endocrinology and Metabolism, Herlev University Hospital, DK-2730 Herlev, Denmark

More Information

Publications:

Finley DJ, Zhu B, Barden CB, Fahey TJ 3rd. Discrimination of benign and malignant thyroid nodules by molecular profiling. Ann Surg. 2004 Sep;240(3):425-36; discussion 436-7.

Study ID Numbers:	HH-FB-10
Study First Received:	February 27, 2006
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00297297 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Herlev Hospital:

Solitary solid and scintigraphically cold thyroid nodules

Study placed in the following topic categories:

Thyroid Neoplasms
Thyroid Nodule
Head and Neck Neoplasms
Endocrine System Diseases

Endocrinopathy
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Thyroid Neoplasms
Thyroid Nodule

Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009