NCT00316823

Brief Summary

RATIONALE: Finding genetic markers for thyroid cancer in a biopsy specimen may help doctors diagnose thyroid cancer. PURPOSE: This clinical trial is studying how well genetic analysis works in diagnosing thyroid cancer in patients with thyroid nodules.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

February 24, 2014

Status Verified

December 1, 2008

Enrollment Period

4.4 years

First QC Date

April 19, 2006

Last Update Submit

February 21, 2014

Conditions

Head and Neck Cancer

Keywords

thyroid cancer

Outcome Measures

Primary Outcomes (2)

  • Diagnostic accuracy of biomarkers by mRNA expression analysis

  • Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples

Interventions

gene expression analysisGENETIC
polymerase chain reactionGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
diagnostic laboratory biomarker analysisOTHER
immunohistochemistry staining methodOTHER
needle biopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of a thyroid nodule that requires fine-needle aspiration biopsy or thyroidectomy to exclude a diagnosis of thyroid cancer PATIENT CHARACTERISTICS: * Platelet count ≥ 70,000/mm\^3 * PT (INR) ≤ 14.5 * PTT ≤ 35.2 * Not pregnant PRIOR CONCURRENT THERAPY: * No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) 7 days before sample procurement

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsThyroid Neoplasms

Interventions

Gene Expression ProfilingPolymerase Chain ReactionReverse Transcriptase Polymerase Chain ReactionImmunohistochemistryBiopsy, Needle

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesNucleic Acid Amplification TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic TechniquesBiopsyCytodiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePunctures

Study Officials

  • Electron Kebebew, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2006

First Posted

April 21, 2006

Study Start

July 1, 2005

Primary Completion

December 1, 2009

Last Updated

February 24, 2014

Record last verified: 2008-12

Locations

US(1)