Protein Classifier for Thyroid Indeterminate Nodules

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04477798

Enrollment

320

Registered

2020-07-20

Start date

2020-08-01

Completion date

2021-12-31

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

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.

Interventions

DIAGNOSTIC_TESTPCT-DIA/MS

PCT-DIA/MS will be validated to classify FNA biopsy specimens

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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).

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactDingcun Luo

wlsydxjk@163.com+86057156005600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026