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OpenTrials
Completed

NCT Number: NCT04551287

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

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.

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Key information

Conditions

Cervical Cancer Artificial Intelligence Diagnosing Cervical Cytology Grades and Cancer Diagnostic Platform Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Guangzhou Women and Children's Medical Center, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women Aged 25-65 years old.
  • 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

  • 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.
  • Women diagnosed with other malignant tumors other than cervical cancer.

Treatment and study plan

Primary outcomes

  1. Area under ROC curve (AUC)

    Time frame: Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained

    Area under the curve

Secondary outcomes

  1. Specificity

    Time frame: Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained

    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 (%).

  2. Sensitivity

    Time frame: Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained

    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 (%).

  3. Accuracy

    Time frame: Diagnostic evaluation will be performed within 1 week when the smear pictures are obtained

    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).

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Collaborators

  • Guangzhou Women and Children's Medical Center
  • The Third Affiliated Hospital of Guangzhou Medical University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Aug 8, 2023

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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