Thyroid cancer
Conditions
Interventions
Gold Standard:Postoperative Paraffin Pathology Diagnosis
Index test:AI Thyroid Nodule Diagnostic Software
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects who can be enrolled in this trial must meet all of the following criteria: 1. Aged 18-75 years, of any gender; Evaluation of the clinical trial report on the efficacy and safety of ultrasound-assisted diagnostic software for thyroid nodules. 2. Subjects with an indication for thyroid nodule puncture (meeting any of the following conditions): (1). Clinically suspected malignant nodule >=5 mm, and the patient is willing to undergo surgery; (2). Clinically suspected benign nodule >=20 mm, and the patient is willing to undergo surgery; (3). Clinically suspected malignant nodule with a concomitant benign nodule >=5 mm on the contralateral side, and the patient is willing to undergo surgery. 3.The subject voluntarily participates in the trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects should not participate in the trial if any of the following conditions apply: 1. Contraindications to thyroid fine-needle aspiration biopsy (meeting any of the following conditions): (1).Patients with a bleeding tendency, or with acute local redness, swelling, or inflammation; (2).Patients with a highly sensitive constitution or other hypersensitivity reactions; (3).Patients whose nodules are deep, small, or highly mobile, making biopsy difficult to perform successfully; (4).Cases where the biopsy needle path may damage nearby vital organs; (5).Patients with varying degrees of systemic failure or who cannot tolerate thyroid biopsy procedures. 2.Uncontrolled subacute thyroiditis or hyperthyroidism; 3. Patients who have undergone thyroid nodule biopsy of the target nodule within the past six months; 4. Patients with a history of thyroid nodule ablation; 5. Patients with a history of atrial fibrillation or severe arrhythmias; 6. Patients with major diseases affecting the heart, lungs, liver, kidneys, or other vital organs; 7. Patients with cancer-related cachexia syndrome; 8. Patients with a history of psychiatric disorders or cognitive impairment; 9. Pregnant or breastfeeding women; 10. Patients who have participated in other clinical trials within the past 90 days; 11. Other reasons deemed by the investigator that make the patient unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy;Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactJingqiang Zhu
West China Hospital, Sichuan University
Outcome results
None listed