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

NCT ID: NCT03105648

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2026-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Computerized Cytomorphometry

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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thyroid cancer

computerized cytomorphometry

Intervention Type OTHER

use computer program to analyse the characteristics of thyroid cells obtained by fine needle aspiration cytology examination

benign thyroid nodules

computerized cytomorphometry

Intervention Type OTHER

use computer program to analyse the characteristics of thyroid cells obtained by fine needle aspiration cytology examination

Interventions

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computerized cytomorphometry

use computer program to analyse the characteristics of thyroid cells obtained by fine needle aspiration cytology examination

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients who are younger than 20 years old
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyang-Rong Shih, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospita

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shyang-Rong Shih, Ph.D.

Role: CONTACT

886-972653337

Facility Contacts

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Chia-Chun Ho

Role: primary

+886-2-3366 ext. 8657

Other Identifiers

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201603064RIPB

Identifier Type: -

Identifier Source: org_study_id

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