Back to resultsProtein Classifier for Thyroid Indeterminate Nodules
Primary Purpose
Thyroid Nodule
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PCT-DIA/MS
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodule
Eligibility Criteria
Inclusion Criteria:
- Patients with aged 18 to 70 years old;
- Patients with thyroid nodules who have not been treated with drugs;
- Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;
- Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;
- Patients voluntarily participate in the study after informed consent.
Exclusion Criteria:
- Patients without operation;
- Patients with insufficient FNA sample size (judged by the laboratory).
Sites / Locations
- Hangzhou First People's Hospital Affiliated to Zhejiang University Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PCT-DIA/MS
Arm Description
PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules
Outcomes
Primary Outcome Measures
protein classifier
classify thyroid indeterminate nodules as Benign or Malignant
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04477798
Brief Title
Protein Classifier for Thyroid Indeterminate Nodules
Official Title
Protein Classifier for Thyroid Indeterminate Nodules： a Multi-center Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luo Dingcun
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PCT-DIA/MS
Arm Type
Experimental
Arm Description
PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules
Intervention Type
Diagnostic Test
Intervention Name(s)
PCT-DIA/MS
Intervention Description
PCT-DIA/MS will be validated to classify FNA biopsy specimens
Primary Outcome Measure Information:
Title
protein classifier
Description
classify thyroid indeterminate nodules as Benign or Malignant
Time Frame
immediately after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with aged 18 to 70 years old;
Patients with thyroid nodules who have not been treated with drugs;
Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;
Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;
Patients voluntarily participate in the study after informed consent.
Exclusion Criteria:
Patients without operation;
Patients with insufficient FNA sample size (judged by the laboratory).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dingcun Luo
Phone
+86057156005600
Email
wlsydxjk@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dingcun Luo
Organizational Affiliation
First People's Hospital of Hangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
317500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingcun Luo
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Protein Classifier for Thyroid Indeterminate Nodules
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