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A registration clinical trial of Ultrasonic imaging-assisted diagnosis software for thyroid nodules

A prospective, paired, multi-center clinical trial to evaluate the accuracy of the ultrasound imaging-assisted diagnosis software for thyroid nodules in assisting doctors in diagnosing the benign and malignant tendencies of thyroid nodules in thyroid ultrasound grayscale images

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100051529
Enrollment
Unknown
Registered
2021-09-26
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Thyroid nodules

Interventions

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Sponsors

Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old; 2. Patients with thyroid nodules found by thyroid ultrasonography; 3. Voluntarily participate in this clinical trial and have signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone thyroid nodule resection, ablation, radiotherapy, and chemotherapy; 2. Patients who have participated in other clinical trials 30 days before enrollment; 3. There are other circumstances that the investigator considers unsuitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
The sensitivity and specificity of the experimental device used in the test to assist the doctor in reading the image (in the unit of patient);

Secondary

MeasureTime frame
The sensitivity and specificity of the experimental device used in the test to assist the doctor in reading the image (in the unit of nodule);The accuracy and Kappa value of the experimental device used in the test to assist the doctor in reading the image (in the unit of nodule/patient);The sensitivity and specificity of image reading of experimental devices (in the unit of nodule/patient);

Countries

China

Contacts

Public ContactXu Dong

Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital

xudong@zjcc.org.cn+86 571 88122330

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026