Clinical trial NCT03294005: Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography
Official title: Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 1949
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Enrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002 January to 2016 December in CMUH.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy with (TP+TN)/(TP+TN+FP+TN)
timeFrame: Jun 2018
Secondary outcomes:
measure: Sensitivity with TP/(TP+FN)
timeFrame: Jun 2018
measure: Specificity with TN/(TN+FP)
timeFrame: Jun 2018
measure: Positive predictive value (PPV) with TP/(TP+FP)
timeFrame: Jun 2018
measure: Negative predictive value (NPV) with TN/(TN+FN)
timeFrame: Jun 2018
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: