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CompletedNCT03294005Updated Jul 21, 2020

Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography

An observational study in Thyroid Cancer, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by China Medical University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
1,949
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Thyroid Cancer
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Enrolled subjects with nodular goiter had thyroid sonography and thyroidectomy from 2002 January to 2016 December in CMUH.

Inclusion criteria

    1. Patients with nodular goiter had thyroidectomy from 2002 January to 2016 December in CMUH.
    1. Patients had thyroid sonography within one year before thyroidectomy.
    1. All data at least was interpreted by 3 endocrinologists under the blind method.

Exclusion criteria

Exclusion Criteria:

    1. Patients with nodular goiter hadn't thyroidectomy.
    1. Patients hadn't thyroid sonography.
    1. All data was interpreted by endocrinologists under the blind method, but interpretation results were inconsistent.
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
1,949 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: Thyroid ultrasonography

Interventions

  • Diagnostic testThyroid 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.

05

What researchers measure

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

06

Study locations

1 site
  • China Medical University Hospital
    Taichung, Taiwan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03294005
Lead sponsor
China Medical University Hospital
Responsible party
Chwen-Tzuei Chang (Consultant, China Medical University Hospital) — Principal investigator
First posted
Sep 26, 2017
Start date
Jul 1, 2017
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Jul 21, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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