Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00316823
First received: April 19, 2006
Last updated: February 6, 2009
Last verified: December 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: needle biopsy |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Gene Expression Analysis in Thyroid Nodule FNA Samples |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Genetic Testing
Head and Neck Cancer
Thyroid Cancer
Thyroid Diseases
Drug Information available for:
Thyroid
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Diagnostic accuracy of biomarkers by mRNA expression analysis [ Designated as safety issue: No ]
- Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2005 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316823
Locations
| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Electron Kebebew, MD | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00316823 History of Changes |
| Other Study ID Numbers: | CDR0000456480, UCSF-H28355-27029-01, UCSF-05205 |
| Study First Received: | April 19, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
thyroid cancer |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Head and Neck Neoplasms Thyroid Diseases Thyroid Nodule |
Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013