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NCT04477798 Clinical Trial

Protein Classifier for Thyroid Indeterminate Nodules

Thyroid Nodule Clinical Trial

Official title:
Protein Classifier for Thyroid Indeterminate Nodules： a Multi-center Prospective Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04477798
Other study ID # ZhejiangU20200701
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date December 31, 2021

Study information
Verified date July 2020
Source Zhejiang University
Contact Dingcun Luo
Phone +86057156005600
Email wlsydxjk@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In multi-center, prospective, double-blind cohorts, PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules.

Recruitment information / eligibility
Status Recruiting
Enrollment 320
Est. completion date December 31, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Patients with aged 18 to 70 years old;

2. Patients with thyroid nodules who have not been treated with drugs;

3. Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;

4. Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;

5. Patients voluntarily participate in the study after informed consent.

Exclusion Criteria:

1. Patients without operation;

2. Patients with insufficient FNA sample size (judged by the laboratory).

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PCT-DIA/MS
PCT-DIA/MS will be validated to classify FNA biopsy specimens

Locations
Country Name City State
China Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Luo Dingcun

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary protein classifier classify thyroid indeterminate nodules as Benign or Malignant immediately after the procedure
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