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

Completed

• Conditions: FLUS; Thyroid Cancer; Atypia of Undetermined Significance

• Registration Number: NCT04601298
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2015-08-01
• Study First Submitted: 2020-09-29
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-23
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extra-thyroid extension	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 Outcome Measures

Name	Time	Method
Multifocality	from 2015 to 2020	thyroid cancer lesions is more than two;analyze the correlation between multifocality and tumor size.

Trial Locations

Locations (1)

Shanghai 10Th People'S Hospital; 🇨🇳 Shanghai, Shanghai, China