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

Thyroid Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601298
• Other study ID #: Bethesda Category III
• Status: Completed
• Start date: August 1, 2015
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2021
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Atypia of Undetermined Significance
• FLUS
• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
China	Shanghai 10Th People'S Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extra-thyroid extension	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	Multifocality	thyroid cancer lesions is more than two;analyze the correlation between multifocality and tumor size.	from 2015 to 2020