NCT06528236

Brief Summary

Research on automatic detection of ovarian mass and intelligent auxiliary diagnosis system based on multimodal ultrasound images.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Jul 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jul 2024Jul 2029

First Submitted

Initial submission to the registry

July 18, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2029

Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

July 18, 2024

Last Update Submit

July 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Area under the curve

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

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Sensitivity

    Through study completion, an average of 1 year

Other Outcomes (4)

  • Specificity

    Through study completion, an average of 1 year

  • Accuracy

    Through study completion, an average of 1 year

  • Positive predicative value

    Through study completion, an average of 1 year

  • +1 more other outcomes

Study Arms (4)

Training cohort

Training cohort is used to training artificial model based on multimodel ultrasound images or videos.

Validation cohort

Validation cohort is used to validate artificial model.

Diagnostic Test: Artificial intelligence model

Internal test cohort

Internal test cohort is used to internally test artificial model.

Diagnostic Test: Artificial intelligence model

External test cohort

External test cohort is used to internally test artificial model.

Diagnostic Test: Artificial intelligence model

Interventions

Using the artificial intelligence model to diagnosis benign, borderline, and malignant ovarian masses.

External test cohortInternal test cohortValidation cohort

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Histopathological analysis confirms non-ovarian tumor;
  • Histopathological results are inconclusive;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Litao Sun, Professor

    Zhejiang Provincial People's Hospital

    STUDY CHAIR

Central Study Contacts

Yingnan Wu, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 30, 2024

Study Start

July 30, 2024

Primary Completion (Estimated)

July 30, 2029

Study Completion (Estimated)

July 30, 2029

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share