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Gene Expression Analysis in Thyroid Nodule FNA Samples


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Gene Expression Analysis in Thyroid Nodule FNA Samples


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic accuracy of biomarkers by mRNA expression analysis

Safety Issue:

No

Principal Investigator

Electron Kebebew, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

Unspecified

Study ID:

CDR0000456480

NCT ID:

NCT00316823

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • thyroid cancer
  • Thyroid Neoplasms
  • Head and Neck Neoplasms
  • Thyroid Diseases
  • Thyroid Nodule

Name

Location
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115