ThyroidNCT04388956
Thyroid Disease Diagnosis by Mutiple Ultrasonic Factors.
An observational study of Thyroid and Nodule, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid, Nodule, Diagnoses Disease
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to 31 Dec 2022
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators plan to recruit 300 patients who have discrete solid thyroid tumors need to undergo fine-needle aspiration cytology to provide the tentative diagnosis. The inclusion criteria were discrete thyroid tumors with mainly solid content (>50% solid content) and diameter of tumors between 0.5-3cm. The exclusion criteria were abnormal thyroid function, past history of thyroiditis, multinodular goiter, and cystic tumors.
Who may be able to join
- patients who have discrete solid thyroid tumors need to undergo fine-needle aspiration cytology to provide the tentative diagnosis
- discrete thyroid tumors with mainly solid content (>50% solid content) and diameter of tumors between 0.5-3cm
Who cannot join
- abnormal thyroid function, past history of thyroiditis, multinodular goiter, and cystic tumors.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Kuen Yuan Chen, MD, 02-23123456 ext. 65752, dtsurg51@gmail.com
About this study
Official title: Diagnosis of Thyroid Tumors by Multiple Ultrasonic Factors.
In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.
Read the detailed description
4 to 7 percent of adult population has a palpable thyroid nodule and 17% to 27% of cases can be found when examined by sonography. Although the incidence of the thyroid nodules is high, only 1 of 20 clinically identified nodules is malignant.
Several gray scale sonographic characteristics have been suggestive of malignancy, including hypoechoigenicity, micro calcification, blurred margin and intranodular vascularity. The intranodular vascularity has been studied in several researches. But the previous studies usually evaluated the vascularity by color Doppler sonography and only divided into several categories subjectively. And the result is controversial.
The evaluation of the tumor microcirculation by Doppler ultrasound has been used in many tumors and defined as vascularity index (VI). The power Doppler sonography has many advantages over color Doppler ultrasound in studying the vascularity. It is more sensitive, less noisy. Power Doppler can detect the blood flow of small internal tumor vessels with a diameter of less than 100μm at slow flow rates on the order of a few mm per second1,2 According to our previous study, the vascularity index(PDVI) of thyroid tumor by power Doppler ultrasound between benign and malignant one are statistically different.
In the present study, the investigators examine different PDVI of thyroid tumors and the traditional（B-mode）ultrasound features including the heterogeneity, echogenicity, margin status, and the presence of microcalcification. The investigators consider the several factors simultaneously by statistical model (PCA, FLD). In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.
- Conditions
- Thyroid, Nodule, Diagnoses Disease
- Medical subject headings
- Thyroid Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound evaluation
Patients who were eligible for this trial will receive the new model of ultrasound evaluation . The traditional features including echogenicity, margin, heterogeneity, size and the presence of microcalcification will be recorded in the same time. Then the investigators evaluate the thyroid tumor vascularity in sagittal and transverse section by power Doppler mode (wall filter (WF): medium, colour power angiography (CPA): 82, retroperitoneal fibrosis (RPF): 1000). The DICOM data of the vascularity index(PDVI) will be collected and analyzed later.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study startJul 2008
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuen-Yuan Chen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388956
- Sponsor's protocol ID
- 200805039R
- Status last verified
- Jun 2021
- First submitted
- 12 May 2020
- Last updated
- 9 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Thyroid Tumors by Multiple Ultrasonic Factors.
- ClinicalTrials.gov ID
- NCT04388956
- Acronym / sponsor ID
- 200805039R
- Conditions
- Thyroid, Nodule, Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 May 2020 (actual)
- 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.
In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.
Detailed description
4 to 7 percent of adult population has a palpable thyroid nodule and 17% to 27% of cases can be found when examined by sonography. Although the incidence of the thyroid nodules is high, only 1 of 20 clinically identified nodules is malignant.
Several gray scale sonographic characteristics have been suggestive of malignancy, including hypoechoigenicity, micro calcification, blurred margin and intranodular vascularity. The intranodular vascularity has been studied in several researches. But the previous studies usually evaluated the vascularity by color Doppler sonography and only divided into several categories subjectively. And the result is controversial.
The evaluation of the tumor microcirculation by Doppler ultrasound has been used in many tumors and defined as vascularity index (VI). The power Doppler sonography has many advantages over color Doppler ultrasound in studying the vascularity. It is more sensitive, less noisy. Power Doppler can detect the blood flow of small internal tumor vessels with a diameter of less than 100μm at slow flow rates on the order of a few mm per second1,2 According to our previous study, the vascularity index(PDVI) of thyroid tumor by power Doppler ultrasound between benign and malignant one are statistically different.
In the present study, the investigators examine different PDVI of thyroid tumors and the traditional（B-mode）ultrasound features including the heterogeneity, echogenicity, margin status, and the presence of microcalcification. The investigators consider the several factors simultaneously by statistical model (PCA, FLD). In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators plan to recruit 300 patients who have discrete solid thyroid tumors need to undergo fine-needle aspiration cytology to provide the tentative diagnosis. The inclusion criteria were discrete thyroid tumors with mainly solid content (>50% solid content) and diameter of tumors between 0.5-3cm. The exclusion criteria were abnormal thyroid function, past history of thyroiditis, multinodular goiter, and cystic tumors.
Key inclusion criteria (2 listed)
- patients who have discrete solid thyroid tumors need to undergo fine-needle aspiration cytology to provide the tentative diagnosis
- discrete thyroid tumors with mainly solid content (>50% solid content) and diameter of tumors between 0.5-3cm
Key exclusion criteria (1 listed)
- abnormal thyroid function, past history of thyroiditis, multinodular goiter, and cystic tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ultrasound evaluation
Time frame: 3 days
Patients who were eligible for this trial will receive the new model of ultrasound evaluation . The traditional features including echogenicity, margin, heterogeneity, size and the presence of microcalcification will be recorded in the same time. Then the investigators evaluate the thyroid tumor vascularity in sagittal and transverse section by power Doppler mode (wall filter (WF): medium, colour power angiography (CPA): 82, retroperitoneal fibrosis (RPF): 1000). The DICOM data of the vascularity index(PDVI) will be collected and analyzed later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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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.
Kuen-Yuan Chen, MD principal investigator
National Taiwan University Hospital
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 and Nodule, run by National Taiwan University 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 2 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 9 Jun 2021. 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 Kuen-Yuan Chen, MD (886-2-23123456 ext. 65752, dtsurg51@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound evaluation (time frame: 3 days). 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 9 Jun 2021.