Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography

July 20, 2020 updated by: Chwen-Tzuei Chang, China Medical University Hospital

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1949

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Accuracy with (TP+TN)/(TP+TN+FP+TN)
Time Frame: Jun 2018
Jun 2018

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Sensitivity with TP/(TP+FN)
Time Frame: Jun 2018
Jun 2018
Specificity with TN/(TN+FP)
Time Frame: Jun 2018
Jun 2018
Positive predictive value (PPV) with TP/(TP+FP)
Time Frame: Jun 2018
Jun 2018
Negative predictive value (NPV) with TN/(TN+FN)
Time Frame: Jun 2018
Jun 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMUH-ENDO2054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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