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OpenTrials
Completed

NCT Number: NCT04601298

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

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.

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Key information

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai 10Th People'S Hospital

Shanghai, Shanghai Municipality, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Multifocality

    Time frame: from 2015 to 2020

    thyroid cancer lesions is more than two;analyze the correlation between multifocality and tumor size.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2020
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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