Clinical trial NCT04601298: The Risk Stratification of Papillary Thyroid Cancer With AUS/FLUS by FNA
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Atypia of Undetermined Significance
FLUS
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Extra-thyroid extension
timeFrame: from 2015 to 2020
Secondary outcomes:
measure: Multifocality
timeFrame: from 2015 to 2020
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10Th People'S Hospital
state: Shanghai
Study officials:
References: