Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography

Thyroid Cancer Clinical Trial

Official title:

Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294005
• Other study ID #: CMUH-ENDO2054
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1949
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Diagnostic Test:
• Thyroid ultrasonography
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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy with (TP+TN)/(TP+TN+FP+TN)		Jun 2018
Secondary	Sensitivity with TP/(TP+FN)		Jun 2018
Secondary	Specificity with TN/(TN+FP)		Jun 2018
Secondary	Positive predictive value (PPV) with TP/(TP+FP)		Jun 2018
Secondary	Negative predictive value (NPV) with TN/(TN+FN)		Jun 2018