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

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ClinicalTrials.gov Identifier: NCT04601298
Recruitment Status : Completed
First Posted : October 23, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Shen Qu, Shanghai 10th People's Hospital

Study Description
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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.


Condition or disease
Thyroid Cancer Atypia of Undetermined Significance FLUS

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 Design
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Study Type : Observational
Actual Enrollment : 290 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
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
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
AUS
FLUS


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Multifocality [ Time Frame: from 2015 to 2020 ]
    thyroid cancer lesions is more than two;analyze the correlation between multifocality and tumor size.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601298


Locations
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China, Shanghai
Shanghai 10Th People'S Hospital
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
More Information
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Responsible Party: Shen Qu, PI, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT04601298    
Other Study ID Numbers: Bethesda Category III
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Adenocarcinoma, Papillary
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type