NCT00297297

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
2.8 years until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 25, 2010

Status Verified

October 1, 2007

First QC Date

February 27, 2006

Last Update Submit

February 24, 2010

Conditions

Thyroid Nodules

Keywords

Solitary solid and scintigraphically cold thyroid nodules

Interventions

No intervention. Applying gene profiling on needle aspiratesOTHER
Also known as: Genetics - molecular profiling of tissue samples

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Pregnancy and lactation
  • Age below 20 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of The Department of Endocrinology, Herlev University Hospital

Copenhagen, 2730, Denmark

Location

Related Publications (1)

  • 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. doi: 10.1097/01.sla.0000137128.64978.bc.

    PMID: 15319714RESULT

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

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

Study Officials

  • Finn N Bennedbaek, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2006

First Posted

February 28, 2006

Study Start

December 1, 2008

Study Completion

March 1, 2011

Last Updated

February 25, 2010

Record last verified: 2007-10

Locations

DK(1)