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Completed

NCT Number: NCT06258044

The Application Value of Deep Learning-Based Nomograms in Benign-Malignant Discrimination of TI-RADS Category 4 Thyroid Nodules

This retrospective study focuses on benign and malignant classification of thyroid nodules using deep learning techniques and evaluates the value of deep learning based nomograms in the classification of TI-RADS category 4 thyroid nodules to improve the accuracy of benign and malignant identification of TI-RADS category 4 thyroid nodules.

Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.

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Key information

Age range

23 year–78 year

Sex eligibility

All sexes

Study type

Observational

Primary location

QianfoshanH

Jinan, Shandong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ultrasound-confirmed diagnosis of thyroid nodules that are classified as TI-RADS category 4.
  • Availability of pathological results.

Exclusion criteria

  • Lack of pathological diagnosis.
  • History of thyroid surgery or other treatments.
  • Poor quality of ultrasound images of thyroid nodules.
  • Incomplete clinical and imaging data of the patient.

Treatment and study plan

Primary outcomes

  1. deep learning prediction model(YOLOv3) and the model evaluation

    Time frame: Immediately evaluated after the prediction model was built

    Based on the characteristics of benign and malignant thyroid nodules, the dataset was divided into a training set and a test set using the cross-validation method, and the YOLOv3 model was trained using data from the training set, and the performance of the model was evaluated using data from the test set.The model is evaluated using a number of metrics such as: precision-recall curve, effective classification precision, confusion matrix and area under the curve.

  2. nomogram prediction and assessment

    Time frame: Immediately evaluated after the nomogram was built

    Factoring clinical features, ultrasound grading and model predictions to map nomograms using R language.Evaluation of the nomogram using various metrics, including subject operating characteristic curves, calibration curves and decision curve analysis

  3. Selection of clinical features and assessment

    Time frame: After the dataset is collected and pathology results are obtained, the statistical results obtained are analyzed for clinical factors, averaging about 1 year.

    The researchers selected patients with TI-RADS category 4 thyroid nodules within 1 year to comprise the dataset. The researchers analyzed the clinical factors in the dataset and analyzed the significance of these clinical factors on the statistical results and clinical characteristics using the Wilcoxon two-sample rank sum test or chi-square test.

  4. Impact and assessment of ultrasound grading

    Time frame: The graded results of the ultrasound examination were analyzed after the data set collection was completed, the ultrasound examination was completed and the final pathology results were obtained, on average about 1 year.

    The researchers selected patients with TI-RADS category 4 thyroid nodules within 1 year to comprise the dataset. The researchers analyzed the results of grading TI-RADS category 4 nodules in this dataset and determined the significance of ultrasound grading on the statistical results using the chi-square test.

Sponsors and collaborators

Lead sponsor

Ma Zhe

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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