Thyroid CancerNCT03294005
Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography
An observational study of Thyroid Cancer, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Iodine ingestion insufficiency was widespread existence in the 50's in Taiwan, induced the hypothyroidism with the popular name "the big neck". After many experts study and evaluation, goiter was gradually disappeared after salt adding iodine in the 60's. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Thyroid ultrasonography
- How many people
- 1,949 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2017to 30 Jun 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002 January to 2016 December in CMUH.
Who may be able to join
- 1. Patients with nodular goiter had thyroidectomy from 2002 January to 2016 December in CMUH.
- 2. Patients had thyroid sonography within one year before thyroidectomy.
- 3. All data at least was interpreted by 3 endocrinologists under the blind method.
Who cannot join
- 1. Patients with nodular goiter hadn't thyroidectomy.
- 2. Patients hadn't thyroid sonography.
- 3. All data was interpreted by endocrinologists under the blind method, but interpretation results were inconsistent.
Trial locations and contacts
1 site in 1 country.
About this study
Iodine ingestion insufficiency was widespread existence in the 50's in Taiwan, induced the hypothyroidism with the popular name "the big neck". After many experts study and evaluation, goiter was gradually disappeared after salt adding iodine in the 60's. But the nodule of the thyroid gland was widespread on the Taiwan island. This situation was a particular victim in living in the mountainous area inhabitant. The middle area populaces suffer from the thyroid gland disease really popular than other areas. Recently literature reported that the cancer rate of thyroid gland rises gradually. In according to the statistics, thyroid cancer prevalence probably has 10% in the nodular goiter.
The major early preliminary diagnosis of the thyroid cancer is thyroid fine-needle aspiration cytology (FNAC), but this technique must to have skilled clinical puncture's doctor and to have special training cytological pathology doctor. Therefore, if we can have simple fast screening tool and can make up this insufficiency, then we can achieved the fast diagnosis, rapid processing, the promotion diagnosis and treatment quality and promotes the survival percentage. The thyroid ultrasonography (Thyroid US) is one universal, fast, cheap, and the simple diagnosis nodular goiter tool. If we can friendly use this tool, we can early diagnosis \& management this disease.
This research collect subjects from Jan 2002 to Dec 2016 under procedure of thyroid US, FNAC and thyroidectomy. Preliminary design index of thyroid gland tumor score (TTS) was to survey and analysis.
- Conditions
- Thyroid Cancer
- Being tested
- Thyroid ultrasonography
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid ultrasonographyDiagnostic test
Each subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with nodular goiter | Enrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002 January to 2016 December in CMUH. Total enrolled subject about 2000. These subjects were confirmed by pathology. Each subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients. Gray scale ultrasonography was routinely performed in every subject. Color Doppler ultrasonography for blood flow and thyroid fine needle aspiration was not absolute done in routine procedure. All data at least was interpreted by 3 endocrinologists under the blind method. Each subject was analyzed under thyroid echogenicity, margin, calcification, inclusion, grooving change and size \& ratio size of tall and transverse. Receives: Diagnostic Test: Thyroid ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy with (TP+TN)/(TP+TN+FP+TN)
Measured: Jun 2018
Secondary outcomes (4)
Sensitivity with TP/(TP+FN)
Measured: Jun 2018
Specificity with TN/(TN+FP)
Measured: Jun 2018
Positive predictive value (PPV) with TP/(TP+FP)
Measured: Jun 2018
Negative predictive value (NPV) with TN/(TN+FN)
Measured: Jun 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Jul 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by China Medical 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,949 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chwen-Tzuei Chang, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294005
- Sponsor's protocol ID
- CMUH-ENDO2054
- Status last verified
- Jul 2020
- First submitted
- 22 Sep 2017
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography
- ClinicalTrials.gov ID
- NCT03294005
- Acronym / sponsor ID
- CMUH-ENDO2054
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,949 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 Sep 2017 (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.
Iodine ingestion insufficiency was widespread existence in the 50's in Taiwan, induced the hypothyroidism with the popular name "the big neck". After many experts study and evaluation, goiter was gradually disappeared after salt adding iodine in the 60's. But the nodule of the thyroid gland was widespread on the Taiwan island. This situation was a particular victim in living in the mountainous area inhabitant. The middle area populaces suffer from the thyroid gland disease really popular than other areas. Recently literature reported that the cancer rate of thyroid gland rises gradually. In according to the statistics, thyroid cancer prevalence probably has 10% in the nodular goiter.
The major early preliminary diagnosis of the thyroid cancer is thyroid fine-needle aspiration cytology (FNAC), but this technique must to have skilled clinical puncture's doctor and to have special training cytological pathology doctor. Therefore, if we can have simple fast screening tool and can make up this insufficiency, then we can achieved the fast diagnosis, rapid processing, the promotion diagnosis and treatment quality and promotes the survival percentage. The thyroid ultrasonography (Thyroid US) is one universal, fast, cheap, and the simple diagnosis nodular goiter tool. If we can friendly use this tool, we can early diagnosis \& management this disease.
This research collect subjects from Jan 2002 to Dec 2016 under procedure of thyroid US, FNAC and thyroidectomy. Preliminary design index of thyroid gland tumor score (TTS) was to survey and analysis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with nodular goiter | – | Diagnostic Test: Thyroid ultrasonographyEnrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002 January to 2016 December in CMUH. Total enrolled subject about 2000. These subjects were confirmed by pathology. Each subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients. Gray scale ultrasonography was routinely performed in every subject. Color Doppler ultrasonography for blood flow and thyroid fine needle aspiration was not absolute done in routine procedure. All data at least was interpreted by 3 endocrinologists under the blind method. Each subject was analyzed under thyroid echogenicity, margin, calcification, inclusion, grooving change and size \& ratio size of tall and transverse. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002 January to 2016 December in CMUH.
Key inclusion criteria (3 listed)
- 1. Patients with nodular goiter had thyroidectomy from 2002 January to 2016 December in CMUH.
- 2. Patients had thyroid sonography within one year before thyroidectomy.
- 3. All data at least was interpreted by 3 endocrinologists under the blind method.
Key exclusion criteria (3 listed)
- 1. Patients with nodular goiter hadn't thyroidectomy.
- 2. Patients hadn't thyroid sonography.
- 3. All data was interpreted by endocrinologists under the blind method, but interpretation results were inconsistent.
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 ultrasonographyEach subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients. | Diagnostic test | Subjects with nodular goiter |
Primary outcome
Accuracy with (TP+TN)/(TP+TN+FP+TN)
Time frame: Jun 2018
4 secondary outcomes
Sensitivity with TP/(TP+FN)
Time frame: Jun 2018
Specificity with TN/(TN+FP)
Time frame: Jun 2018
Positive predictive value (PPV) with TP/(TP+FP)
Time frame: Jun 2018
Negative predictive value (NPV) with TN/(TN+FN)
Time frame: Jun 2018
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 21 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, run by China Medical 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 3 inclusion and 3 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 21 Jul 2020. 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?
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?
Accuracy with (TP+TN)/(TP+TN+FP+TN) (time frame: Jun 2018). 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 21 Jul 2020; AzTrials last refreshed its copy on 3 Nov 2026.