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OpenTrials
Completed

NCT Number: NCT00316823

Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules

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.

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Key information

Conditions

Head and Neck Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

About this study

OBJECTIVES:

  • Evaluate the diagnostic accuracy of biomarkers and mRNA expression analysis using fine-needle aspiration (FNA) biopsy samples from patients with thyroid nodules.
  • Correlate the level of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples.

OUTLINE: Patients undergo fine-needle aspiration (FNA) biopsy as part of routine care. Additional thyroid tissue is collected during the biopsy for gene expression analysis. Patients who have already had a biopsy undergo FNA biopsy during thyroidectomy.

Tissue samples will be examined for gene expression by reverse transcriptase-polymerase chain reaction (PCR), real-time quantitative PCR, and immunohistochemistry.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

polymerase chain reaction

Genetic

reverse transcriptase-polymerase chain reaction

Genetic

diagnostic laboratory biomarker analysis

Other

immunohistochemistry staining method

Other

needle biopsy

Procedure

Primary outcomes

  1. Diagnostic accuracy of biomarkers by mRNA expression analysis

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Gene Expression Analysis in Thyroid Nodule FNA Samples

Important dates

Study start
2005
Primary completion
2009
First posted
Apr 21, 2006
Registry last updated
Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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