Head and Neck CancerNCT00316823
Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
A study testing gene expression analysis, polymerase chain reaction and reverse transcriptase-polymerase chain reaction in people with Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- gene expression analysis, polymerase chain reaction and reverse transcriptase-polymerase chain reaction
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Gene Expression Analysis in Thyroid Nodule FNA Samples
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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer
- Being tested
- gene expression analysis, polymerase chain reaction, reverse transcriptase-polymerase chain reaction, diagnostic laboratory biomarker analysis, immunohistochemistry staining method
- Keywords
- thyroid cancer
- Medical subject headings
- Head and Neck Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
polymerase chain reactionGenetic
reverse transcriptase-polymerase chain reactionGenetic
diagnostic laboratory biomarker analysisOther
needle biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of biomarkers by mRNA expression analysis
Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startJul 2005
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Electron Kebebew, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316823
- Sponsor's protocol ID
- CDR0000456480
- Other IDs
- UCSF-H28355-27029-01, UCSF-05205
- Status last verified
- Dec 2008
- First submitted
- 19 Apr 2006
- Last updated
- 24 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Analysis in Thyroid Nodule FNA Samples
- ClinicalTrials.gov ID
- NCT00316823
- Acronym / sponsor ID
- CDR0000456480
- Conditions
- Head and Neck Cancer
- Keywords
- thyroid cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2005
- Primary completion
- Dec 2009
- First posted
- 21 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | – |
Primary outcome
Diagnostic accuracy of biomarkers by mRNA expression analysis
Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electron Kebebew, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gene expression analysis, polymerase chain reaction and reverse transcriptase-polymerase chain reaction in people with Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of biomarkers by mRNA expression analysis. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.