Protein Classifier for Thyroid Indeterminate Nodules

Not Applicable

• Conditions: Thyroid Nodule
• Interventions: Diagnostic Test: PCT-DIA/MS

• Registration Number: NCT04477798
• Lead Sponsor: Luo Dingcun

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-20
• Last Update Posted: 2020-07-20
• Study Start: 2020-08-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCT-DIA/MS	PCT-DIA/MS	PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules

Primary Outcome Measures

Name	Time	Method
protein classifier	immediately after the procedure	classify thyroid indeterminate nodules as Benign or Malignant

Trial Locations

Locations (1)

Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College; 🇨🇳 Hangzhou, Zhejiang, China