Improved Preoperative Selection of Cold Thyroid Nodules

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2007 by Herlev Hospital.
Recruitment status was: Enrolling by invitation

Sponsor:

Information provided by:

Herlev Hospital

ClinicalTrials.gov Identifier:

NCT00297297

First received: February 27, 2006

Last updated: February 24, 2010

Last verified: October 2007

History of Changes

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	Other: No intervention. Applying gene profiling on needle aspirates	Phase 3


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Preoperative Selection of Solitary Solid Cold Thyroid Nodules - A Prospective Study on the Value of Sonography, Cytology, Immunostaining and Molecular Profiling

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases

Drug Information available for: Thyroid

U.S. FDA Resources

Further study details as provided by Herlev Hospital:


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

Intervention Details:

Other Name: Genetics - molecular profiling of tissue samples

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Tertiary referral center (Endocrine outpatient - University Hosiptal - clinic). Patients referred with a solitary thyroid nodule

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

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: 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.


Responsible Party:	Finn N Bennedbaek, Md, PhD (principal investigator), Herlev University Hospital
ClinicalTrials.gov Identifier:	NCT00297297 History of Changes
Other Study ID Numbers:	HH-FB-10
Study First Received:	February 27, 2006
Last Updated:	February 24, 2010

Keywords provided by Herlev Hospital:


Solitary solid and scintigraphically cold thyroid nodules

Additional relevant MeSH terms:


Thyroid Diseases Thyroid Nodule Thyroid Neoplasms Endocrine System Diseases	Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 19, 2017

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