The Risk Stratification of Papillary Thyroid Cancer With AUS/FLUS by FNA

March 15, 2021 updated by: Shen Qu, Shanghai 10th People's Hospital

The Risk Stratification of Papillary Thyroid Cancer With Bethesda Category III（AUS/FLUS）by Thyroid Fine-Needle Aspiration（FNA）Could be Assisted by Tumor Size for Precision Treatment

Purpose: To investigate the clinical characteristics of papillary thyroid cancer (PTC) with Bethesda category III (AUS/FLUS) by fine needle aspiration (FNA) and to assisted the precision treatment.

Methods:A total of 290 patients who underwent thyroidectomies or thyroid lobectomies from August 2015 to September 2020, following a diagnosis of Bethesda category III (AUS/FLUS) from preoperative thyroid FNA were investigated.

Groups: In order to investigate the clinopathologic characteristics, the patients, were grouped according to Cytology,Gender, Tumor size.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: To investigate the clinical characteristics of papillary thyroid cancer (PTC) with Bethesda category III (AUS/FLUS) by fine needle aspiration (FNA) and to assisted the precision treatment.

Methods:A total of 1739 cases diagnosed with Bethesda category III (AUS/FLUS) by FNA from August 2015 to September 2020 were reviewed, and 523 patients received thyroidectomy or lobectomy. 290 patients were diagnosed with PTC and investigated retrospectively.

Groups: In order to investigate the clinopathologic characteristics, the patients, were grouped according to Cytology,Gender, Tumor size.as follows:AUS and FLUS&AUS/FLUS;male and female; tumor size≤1cm and>1cm.

Study Type

Observational

Enrollment (Actual)

290

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Shanghai 10th People's 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

Ages Eligible for Study

18 years to 77 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The clinical database for patients undergoing thyroidectomies or thyroid lobectomies at the university hospital from August 2015 to September 2020 was revisited, and the thyroid pathology reports were screened and reviewed to analyse the comparison analysis of thyroid cancer with Bethesda category III (AUS/FLUS) by fine-needle aspiration cytology.

Description

Inclusion Criteria:

Clinical cytology diagnosis of Bethesda category III (AUS/FLUS) pathological confirmation of thyroid malignancy after surgery.

Exclusion Criteria:

  1. pathological confirmation of other thyroid carcinomas, including follicular carcinoma ,medullary carcinoma ,undifferentiated Spindle cell carcinoma and lymphoma were excluded
  2. female who were pregnant were excluded
  3. patients with mental disorders were excluded
  4. patients without the complete clinical data were excluded

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
AUS
FLUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extra-thyroid extension
Time Frame: from 2015 to 2020
Whether there is extension of the primary tumor outside of the thyroid capsule and invasion into surrounding structures. Analyze the correlation between extrathyroid infiltration and tumor size.
from 2015 to 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multifocality
Time Frame: from 2015 to 2020
thyroid cancer lesions is more than two;analyze the correlation between multifocality and tumor size.
from 2015 to 2020

Collaborators and Investigators

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

Sponsor

Shanghai 10th People's 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)

August 1, 2015

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (ACTUAL)

October 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bethesda Category III

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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