Improved Preoperative Selection of Cold Thyroid Nodules | NCT00297297

Studies
Improved Preoperative Selection of Cold Thyroid Nodules

NCT00297297

Sponsor

Herlev Hospital

Status

Unknown status

Last Update Posted

Feb 25, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Thyroid Nodules

Interventions

No intervention. Applying gene profiling on needle aspirates

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Not provided

Completion Date

Mar 2011Estimated

First Submitted Date

Feb 27, 2006

First Submission Date that Met QC Criteria

Feb 27, 2006

First Posted Date

Feb 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2010

Last Update Posted Date

Feb 25, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention. Applying gene profiling on needle aspirates	Other			Genetics - molecular profiling of tissue samples

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Finn N Bennedbaek, MD, PhD	Department of Endocrinology and Metabolism, Herlev University Hospital, DK-2730 Herlev, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Outpatient clinic of The Department of Endocrinology, Herlev University Hospital		Copenhagen		2730	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15319714	Result	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.

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms