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
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:
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 September 15, 2014