Protein Classifier for Thyroid Indeterminate Nodules

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

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.

Study Overview

• Status: Unknown
• Conditions: Thyroid Nodule
• Intervention / Treatment: Diagnostic test: PCT-DIA/MS

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 317500
      • Recruiting
      • Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College
      • Contact: Dingcun Luo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PCT-DIA/MS; PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules	Diagnostic test: PCT-DIA/MS; PCT-DIA/MS will be validated to classify FNA biopsy specimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
protein classifier	classify thyroid indeterminate nodules as Benign or Malignant	immediately after the procedure

Collaborators and Investigators

• Sponsor: Luo Dingcun

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: ZhejiangU20200701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No