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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04551287
Other study ID # 2020-KY-114
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date December 14, 2020

Study information

Verified date August 2023
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16164
Est. completion date December 14, 2020
Est. primary completion date December 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 65 Years
Eligibility 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.

Study Design


Locations

Country Name City State
China Guangzhou Women and Children's Medical Center Guangzhou Guangdong
China Sun Yat-Sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong
China The Third Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (3)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under ROC curve (AUC) Area under the curve Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained
Secondary Specificity The 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 (%). Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained
Secondary Sensitivity The 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 (%). Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained
Secondary Accuracy The 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). Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained
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