Protein Classifier for Thyroid Indeterminate Nodules

• Sponsor: Luo Dingcun (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04477798
• Collaborator: (none)
• Enrollment: 320
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 18.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule	Diagnostic Test: PCT-DIA/MS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 320 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Protein Classifier for Thyroid Indeterminate Nodules： a Multi-center Prospective Clinical Study
• Anticipated Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. protein classifier [immediately after the procedure]

   classify thyroid indeterminate nodules as Benign or Malignant

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College	Hangzhou	Zhejiang	China	317500

Sponsors and Collaborators

• Luo Dingcun

Investigators

• Principal Investigator: Dingcun Luo, First People's Hospital of Hangzhou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Luo Dingcun, vice president of hospital, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04477798
• Other Study ID Numbers: ZhejiangU20200701
• First Posted: Jul 20, 2020
• Last Update Posted: Jul 20, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thyroid Nodule; Thyroid Diseases

Study Results

No Results Posted as of Jul 20, 2020