Research and Application of Ultrasonic Intelligent Diagnosis System for Ovarian Mass

NCT06528236NOT_YET_RECRUITINGOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Zhejiang Provincial People's Hospital

Enrollment

100000

Start Date

2024-07-30

Completion Date

2029-07-30

Study Type

OBSERVATIONAL

Official Title

Research on Automatic Detection of Ovarian Mass and Intelligent Auxiliary Diagnosis System Based on Multimodal Ultrasound Images

Interventions

Artificial intelligence model

Conditions

Ovarian NeoplasmsAdnexal Mass

Eligibility

Sex

FEMALE

Inclusion Criteria:

1. During gynecological ultrasound examination, at least one patient with persistent ovarian tumor was found.
2. The patient underwent surgical treatment and the histopathological results.

Exclusion Criteria:

1. Histopathological analysis confirms non-ovarian tumor;
2. Histopathological results are inconclusive;
3. Issues with image quality: the ovarian mass is incomplete and does not show some surrounding tissues (but the mass is too large to exclude completely); the images are overly blurry, making it difficult to determine the characteristics of the ovarian mass (possible reasons include hardware quality issues with the ultrasound machine, motion blur, focusing problems, presence of intestinal gas in the patient); gain settings make it difficult to judge the characteristics of the ovarian mass (such as low contrast, excessively dark images, or saturation); the presence of artifacts affects the assessment of ultrasound characteristics of the ovarian mass and should be excluded.

Outcome Measures

Primary Outcomes

Area under the curve

AUC (Area Under the Curve) is a common index used to evaluate the performance of binary classification model.

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Sensitivity

Sensitivity refers to the ability of the test to correctly identify a positive result in an individual who actually has the disease. It represents the proportion of cases in which the test is able to detect a positive for the disease

Time frame: Through study completion, an average of 1 year