AI Model for Cervical Cancer Detection From Colposcopy Images

NCT06644248RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Bangladesh University of Engineering and Technology

Enrollment

500

Start Date

2024-01-11

Completion Date

2025-01-11

Study Type

OBSERVATIONAL

Official Title

Development and Evaluation of an Artificial Intelligence Model for Cervical Cancer Detection From Colposcopic Images

Interventions

Colposcopy

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Female patients of age 18 years or older can be selectedas subjects.
* Individuals willing to participate in cervical cancerscreening.
* Availability for colposcopic examination.
* Women with no history of hysterectomy (total removalof the uterus).
* Women with no current or prior diagnosis of cervicalcancer.
* Availability of relevant medical records forconfirmation and comparison purposes.

Exclusion Criteria:

* Pregnant women, given the potential impact onscreening results and the need for specialconsiderations during pregnancy.
* Individuals with severe medical conditions orcircumstances that may make colposcopic examinationinappropriate or unsafe.
* Patients with conditions that could interfere with theaccuracy of the screening results, such as severevaginal bleeding.
* Follow-up screenings.

Outcome Measures

Primary Outcomes

Swede Score Evaluation

The Swede score will be used to evaluate the severity of cervical abnormalities identified in colposcopic images. This scoring system assesses various colposcopic findings, including acetowhiteness, lesion size, and vascular patterns, to determine the effectiveness of the AI model in evaluating cervical abnormalities.

Time frame: 12 hours

Secondary Outcomes

Transformation Zone Classification Accuracy

The metric used includes accuracy, precision, recall, and F1-score for the classification of the transformation zone (TZ) in colposcopic images by the AI model. These metrics will assess the effectiveness of the AI model in identifying and classifying the transformation zone in colposcopic images.

Time frame: 12 hours

Locations

Ibn Sina Medical College Hospital, Dhaka, Bangladesh