Diagnostic and Prognostic Significance of Computerized Cytologic Morphometry of the Thyroid Neoplasm

February 16, 2021 updated by: National Taiwan University Hospital
The prevalence of thyroid nodule is worldwide high. About 40% of normal population has thyroid nodules and about 5% are malignancy. It is important to differentiate malignancy from benign nodules because the management is completely different. Nowadays, the gold standard is fine needle aspiration cytology (FNAC) examination. The overall sensitivity and specificity is fair (~90%), but still has its limitation that some results are indeterminate in about 15% of the nodules. These obstacles are especially troublesome for papillary and follicular thyroid cancer that leads to delayed diagnosis, incomplete resection, and repeated operation. Preoperative evaluation of the prognosis is extraordinary important for cancer management. However, current prognostic scoring systems is only applicable after surgery. Hence, we urgently need a better risk-stratification system for individual-tailored treatment, and genetic-based computerized morphometry study seems to be the most realistic and promising one. The goal of this study is to propose a reliable method for diagnosis and prognosis of papillary thyroid cancer and follicular thyroid cancer through analyzing cellular morphologic characteristics.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

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

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients who previously had received thyroid fine needle aspiration cytology examination

Description

Inclusion Criteria:

  • patients who previously had received thyroid fine needle aspiration cytology examination

Exclusion Criteria:

  • patients who are younger than 20 years old

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
thyroid cancer
Other: computerized cytomorphometry
use computer program to analyse the characteristics of thyroid cells obtained by fine needle aspiration cytology examination
benign thyroid nodules
Other: computerized cytomorphometry
use computer program to analyse the characteristics of thyroid cells obtained by fine needle aspiration cytology examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytomorphometry of the cells
Time Frame: 2016/4/20-2026/4/20
cytologic characteristics of the cells
2016/4/20-2026/4/20

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Shyang-Rong Shih, Ph.D., National Taiwan University Hospita

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)

July 1, 2016

Primary Completion (Anticipated)

April 20, 2026

Study Completion (Anticipated)

April 20, 2026

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201603064RIPB

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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