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Artificial Intelligence Enables Precision Diagnosis of Cervical Cytology Grades and Cervical Cancer

Artificial Intelligence Enables Precision Diagnosis of Cervical Cytology Grades and Cervical Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04551287
Enrollment
16164
Registered
2020-09-16
Start date
2019-07-01
Completion date
2020-12-14
Last updated
2023-08-08

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

Conditions

Artificial Intelligence, Cervical Cancer, Diagnosing Cervical Cytology Grades and Cancer, Diagnostic Platform

Keywords

Diagnostic Platform, Cervical Cytology Grade Diagnosis, Thinprep Cytologic Test, Artificial Intelligence Deep Learning Algorithm

Brief summary

Cervical cancer, the fourth most common cancer globally and the fourth leading cause of cancer-related deaths, can be effectively prevented through early screening. Detecting precancerous cervical lesions and halting their progression in a timely manner is crucial. However, accurate screening platforms for early detection of cervical cancer are needed. Therefore, it is urgent to develop an Artificial Intelligence Cervical Cancer Screening (AICS) system for diagnosing cervical cytology grades and cancer.

Interventions

None listed

Sponsors

Guangzhou Women and Children's Medical Center
CollaboratorOTHER
The Third Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. Women Aged 25-65 years old. 2. Availability of confirmed diagnostic results of the cervical liquid-based cytological examination, and satisfactory digital images from the liquid-based cytology pap test: at least 5000 uncovered and observable squamous epithelial cells, samples with abnormal cells (atypical squamous cells or atypical glandular cells and above).

Exclusion criteria

1. Unsatisfactory samples of cervical liquid-based cytological examination: less than 5000 uncovered, observable squamous epithelial cells, and more than 75% of squamous epithelial cells affected because of blood, inflammatory cells, epithelial cells over-overlapping, poor fixation, excessive drying, or contamination of unknown components. 2. Women diagnosed with other malignant tumors other than cervical cancer.

Design outcomes

Primary

MeasureTime frameDescription
Area under ROC curve (AUC)Diagnostic evaluation will be performed within 1 week when the smear pictures are obtainedArea under the curve

Secondary

MeasureTime frameDescription
SpecificityDiagnostic evaluation will be performed within 1 week when the smear pictures are obtainedThe true negative rate (TNR) of the diagnostic platform, which is the ratio between the number of negative individuals correctly categorized by platform and the total number of actual negative individuals (%).
SensitivityDiagnostic evaluation will be performed within 1 week when the smear pictures are obtainedThe true positive rate (TPR) of the diagnostic platform, which is the ratio between the number of positive individuals correctly categorized by platform and the total number of actual positive individuals (%).
AccuracyDiagnostic evaluation will be performed within 1 week when the smear pictures are obtainedThe quantity of true positive (TP) plus true negative (TN) over the quantity of (TP) plus true negative (TN) plus false positive (FP) plus false negative (FN).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026