Protein Classifier for Thyroid Indeterminate Nodules

Luo Dingcun

Status: Unknown

Conditions: Thyroid Nodule

Treatments: Diagnostic Test: PCT-DIA/MS

Study type: Interventional

Funder types: Other

Identifiers

NCT04477798

ZhejiangU20200701

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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320 participants in 1 patient group

PCT-DIA/MS

Experimental group

Description:

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

Treatment:

Diagnostic Test: PCT-DIA/MS