Improved Preoperative Selection of Cold Thyroid Nodules

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00297297
First received: February 27, 2006
Last updated: February 24, 2010
Last verified: October 2007
  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:


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: No intervention. Applying gene profiling on needle aspirates
    Other Name: Genetics - molecular profiling of tissue samples
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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:
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
Health Authority: Denmark: National Board of Health

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 April 17, 2014