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Thyroid CancerNCT01307761

An Easy Sonographic Scoring System for Predicting Malignant Thyroid Nodules

An observational study of Thyroid Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the investigators study is to retrospectively evaluate the predictors of malignant thyroid nodules and established an useful scoring system based on sonographic findings and demographic data. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Thyroid Cancer
How many people
500 participants
Where
1 siteTaiwan
Study dates
Dec 2010to Aug 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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The investigators want to retrospectively review the medical records of nodules which underwent head and neck ultrasound(US) examination and US-FNA cytology from 2007 July to 2010 Dec at Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan. No patient included in this series had a previous diagnosis of thyroid malignancy.

Who may be able to join

  • nodules which underwent head and neck ultrasound(US) examination and US-FNA cytology from 2007 July to 2010 Dec at Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan.

Who cannot join

  • a previous diagnosis of thyroid malignancy before US exam

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Far Eastern Memorial Hospital

    Taipei

    Recruiting

Other trials in Taiwan

About this study

The purpose of the investigators study is to retrospectively evaluate the predictors of malignant thyroid nodules and established an useful scoring system based on sonographic findings and demographic data.

Read the detailed description

Background:

Some sonographic appearance can help in selection of the correct thyroid nodes to aspirate with US(ultrasound)-guided FNA(fine needle aspiration) biopsy. Findings suggestive for malignant thyroid cancer include micro-calcification, blurred margins, intra-nodular vascular pattern, marked hypoechogenicity or taller-than-wide shape.1-3 However, no single criteria can perfectly predict malignant thyroid nodules. Applied multiple US criteria for the differentiation of thyroid nodule has an overall accuracy ranging from 59.5 to 73.4%.3

Objective:

The purpose of our study is to retrospectively evaluate the predictors of malignant thyroid nodules and established an useful scoring system based on sonographic findings and demographic data.

Material and methods:

This study will be conducted according to the principle of Helsinki declaration and the guidelines of the institutional ethical committee. We want to retrospectively review the medical records of 479 nodules which underwent head and neck ultrasound(US) examination and US-FNA cytology from 2007 July to 2010 Dec at Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan. No patient included in this series had a previous diagnosis of thyroid malignancy.

Equipment for US studies consisted of a color Doppler US unit (Philips HDI 5000, Bothell, WA) and a 5-12 MHz broadband linear array transducer. Nodules were measured with AP and transverse (T) diameters in transverse section. Settings of power Doppler sonography were set for high sensitivity with a low wall filter to allow detection of vessels with low blood flow. The color gain was increased until background noise appeared and then reduced until the noise was suppressed, thus ensuring maximum sensitivity according to Bude and Rubin's description.4 The vascularity types are classified as avascular, peripheral and intra-nodule types1,5. The echo structure (predominantly solid or cyst), internal echo (homogeneous or heterogenicity), echogenicity (hyperechoic, isoechoic, hypoechoic), presented micro-calcification, and characteristics of nodule margin (well-defined or ill defined) were assessed. Thyroid incidentalomas are thyroid nodules without clinically apparent tumor but are incidentally found by US.

US-FNA was carried out with the array probe guiding the placement of a 22-gauge fine needle after informed consent was obtained. The final diagnosis of a lesion as benign (n=449) or malignancy (n=30) was confirmed by FNA biopsy. The relationship between demographic data, sonographic features and final diagnosis, i.e. benign or malignant disease was analyzed in all 479 nodules. In univariate analysis, Chi-square test or Fisher exact test was performed to compare for categorical variables, and student t- test for continuous variables. A stepwise multivariate logistic regression analysis was applied to identify significant independent variables for prophesying malignant nodal disease. The level of significance was set at p < 0.05. The predictive formula was based on multivariate logistic regression analysis and programmed into a real-time, computerized sonographic reporting system. Hosmer-Lemeshow test6 was carried out to verify the significance of the prediction model. The association between prediction score and malignant nodal disease was analyzed using the receiver operating characteristic (ROC) curve. An optimal cutoff point was determined at the point of greatest "sensitivity" with the corresponding smallest "1-specificity".7 The c-value as a measure for the area under the curve represented the diagnostic accuracy of the model.8 All statistical analyses were accomplished using SAS software, version 9.1 (SAS Institute, Inc, Cary, North Carolina).

Expected Results: A simple and practical sonographic scoring system would be built to provide the physician prompt and reliable probability guidance for FNA cytology while managing thyroid nodule.

References:

  1. Cappelli C, Castellano M, Pirola Iet al. The predictive value of ultrasound findings in the management of thyroid nodules. Qjm 2007; 100:29.
  2. Kim E, Park C, Chung Wet al. New sonographic criteria for recommending fine-needle aspiration biopsy of nonpalpable solid nodules of the thyroid. American Journal of Roentgenology 2002; 178:687.
  3. Moon W, Jung S, Lee Jet al. Benign and Malignant Thyroid Nodules: US Differentiation-Multicenter Retrospective Study1. Radiology 2008; 247:762.
  4. Bude R, Rubin J. Power Doppler sonography. Radiology 1996; 200:21.
  5. Rago T, Vitti P, Chiovato Let al. Role of conventional ultrasonography and color flow-doppler sonography in predicting malignancy in'cold'thyroid nodules. European Journal of Endocrinology 1998; 138:41.
  6. Lemeshow S, Hosmer Jr D. A review of goodness of fit statistics for use in the development of logistic regression models. American Journal of Epidemiology 1982; 115:92.
  7. Akobeng A. Understanding diagnostic tests 3: receiver operating characteristic curves. Acta Paediatrica 2007; 96:644-647.
  8. McNeil B, Hanley J. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology 1982; 143:29-36.
Conditions
Thyroid Cancer
Keywords
fine needle aspiration; predictor; ultrasonography; thyroid cancer
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01307761
Study groupRoleWhat they receive
Patients with thyroid nodule received US-FNA examPatients with thyroid nodules which underwent head and neck ultrasound(US) examination and US-FNA cytology at Department of Otolaryngology, Far Eastern Memorial Hospital, Taipei, Taiwan. No patient included in this series had a previous diagnosis of thyroid malignancy before US exam.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2012 (estimated)
  4. Study completionAug 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307761
Sponsor's protocol ID
099144-E
Status last verified
Sep 2011
First submitted
21 Feb 2011
Last updated
19 Sep 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2011. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li-Jen Liao, MD (886-89671592 ext. 4201, deniro@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

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 19 Sep 2011; AzTrials last refreshed its copy on 30 Oct 2026.

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