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Completed

NCT Number: NCT03294005

Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thyroid ultrasonography

Diagnostic 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.

Primary outcomes

  1. Accuracy with (TP+TN)/(TP+TN+FP+TN)

    Time frame: Jun 2018

Secondary outcomes

  1. Sensitivity with TP/(TP+FN)

    Time frame: Jun 2018

  2. Specificity with TN/(TN+FP)

    Time frame: Jun 2018

  3. Positive predictive value (PPV) with TP/(TP+FP)

    Time frame: Jun 2018

  4. Negative predictive value (NPV) with TN/(TN+FN)

    Time frame: Jun 2018

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2017
Registry last updated
Jul 21, 2020

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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