Thyroid NoduleNCT00571090
Prediction of Thyroid Cancer From Ultrasonographic Characteristics of Thyroid Nodules
An observational study of Thyroid Nodule, run by Istanbul Science University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to identify which ultrasonographic feature or a combination of features is the best predictor of thyroid cancer in thyroid nodules. Read more about this study
- Who is it for?
- Ages 15 to 89 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Thyroid ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 735 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2003to Jul 2013
- Phase
- Observational
- 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 15 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Endocrinology Clinic
Who may be able to join
- Subjects with thyroid nodules over 10 mm in the longest diameter
- Euthyroid or hypothyroid subjects with a solitary thyroid nodule or multinodular goiter
- Subjects with a hypoactive nodule in the thyroid scan and a low TSH
Who cannot join
- Subjects with four or more thyroid nodules that are over 10 mm
- Subjects with low TSH and hyperactive nodule on thyroid scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Thyroid Fine Needle Aspiration Biopsies: Prediction of Thyroid Cancer From Ultrasonographic Characteristics of Thyroid Nodules
The aim of this study is to identify which ultrasonographic feature or a combination of features is the best predictor of thyroid cancer in thyroid nodules.
- Conditions
- Thyroid Nodule
- Being tested
- Thyroid ultrasonography
- Keywords
- Thyroid nodule, Biopsy, Fine-Needle
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid ultrasonographyProcedure or surgery
Ultrasound-guided thyroid fine-needle aspiration biopsy
| Study group | Role | What they receive |
|---|---|---|
| Thyroid nodule | Subjects who present with thyroid nodules will be enrolled into the study. Euthyroid and hypothyroid subjects with a solitary thyroid nodule or multinodular goiter will be enrolled. For subjects with a suppressed TSH, a thyroid scan will be performed. Subjects with a hypoactive nodule in the thyroid scan and a low TSH will be enrolled. Receives: Procedure: Thyroid ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid cancer
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startJun 2003
- Primary completionJul 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 735 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Group Florence Nightingale
- Responsible party
- Principal investigator, Ahmet Selcuk Can, Istanbul Science University
- Investigators
- Ahmet Selcuk Can, MD, Principal investigator, Istanbul Science University and Group Florence Nightingale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571090
- Sponsor's protocol ID
- B.30.2.IBU.0.01.00.00/511
- Other IDs
- 511
- Status last verified
- Mar 2014
- First submitted
- 10 Dec 2007
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Can AS. Cost-effectiveness comparison between palpation- and ultrasound-guided thyroid fine-needle aspiration biopsies. BMC Endocr Disord. 2009 May 16;9:14. doi: 10.1186/1472-6823-9-14.
PubMed 19445710
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thyroid Fine Needle Aspiration Biopsies: Prediction of Thyroid Cancer From Ultrasonographic Characteristics of Thyroid Nodules
- ClinicalTrials.gov ID
- NCT00571090
- Acronym / sponsor ID
- B.30.2.IBU.0.01.00.00/511
- Conditions
- Thyroid Nodule
- Keywords
- Thyroid nodule, Biopsy, Fine-Needle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- Istanbul Science UniversityUniversity, hospital or other
- Collaborators
- Group Florence Nightingale
- Study start
- Jun 2003
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Dec 2007 (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.
The aim of this study is to identify which ultrasonographic feature or a combination of features is the best predictor of thyroid cancer in thyroid nodules.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid nodule | – | Procedure: Thyroid ultrasonographySubjects who present with thyroid nodules will be enrolled into the study. Euthyroid and hypothyroid subjects with a solitary thyroid nodule or multinodular goiter will be enrolled. For subjects with a suppressed TSH, a thyroid scan will be performed. Subjects with a hypoactive nodule in the thyroid scan and a low TSH will be enrolled. |
Who may qualify
- Ages
- 15 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Endocrinology Clinic
Key inclusion criteria (3 listed)
- Subjects with thyroid nodules over 10 mm in the longest diameter
- Euthyroid or hypothyroid subjects with a solitary thyroid nodule or multinodular goiter
- Subjects with a hypoactive nodule in the thyroid scan and a low TSH
Key exclusion criteria (2 listed)
- Subjects with four or more thyroid nodules that are over 10 mm
- Subjects with low TSH and hyperactive nodule on thyroid scan
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 |
|---|---|---|
| Thyroid ultrasonographyUltrasound-guided thyroid fine-needle aspiration biopsy | Procedure or surgery | Thyroid nodule |
Primary outcome
Thyroid cancer
Time frame: one year
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 31 Mar 2014.
- Background: PubMed 19445710Can AS. Cost-effectiveness comparison between palpation- and ultrasound-guided thyroid fine-needle aspiration biopsies. BMC Endocr Disord. 2009 May 16;9:14. doi: 10.1186/1472-6823-9-14.
- Free research article from the data of this protocolLink provided by the sponsor.
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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.
Ahmet Selcuk Can, MD principal investigator
Istanbul Science University and Group Florence Nightingale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule, run by Istanbul Science University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 31 Mar 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 Turkey (Türkiye). 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?
Thyroid cancer (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571090, which also lists 1 linked publication.
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 31 Mar 2014.