RecruitingNCT06644248

AI Model for Cervical Cancer Detection From Colposcopy Images

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


Sponsor

Bangladesh University of Engineering and Technology

Enrollment

500 participants

Start Date

Jan 11, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Cervical cancer is a significant health issue, particularly in low-income countries, where late diagnosis and limited access to screenings contribute to high mortality rates. This study aims to develop and evaluate an artificial intelligence (AI) model to analyze colposcopic images for detecting cervical cancer more accurately and efficiently. Colposcopy, a procedure used to examine the cervix for signs of cancer, relies heavily on doctors' expertise, leading to inconsistent results. The current gold standard, colposcopy-directed biopsy, is invasive and can cause complications. The hypothesis is that an AI model can outperform traditional methods in identifying cervical abnormalities, providing a reliable and scalable solution for early detection, especially in underserved areas. By automating the analysis process, the AI model aims to reduce reliance on trained personnel, making cervical cancer screening more accessible and improving early diagnosis and treatment outcomes. The study will create a diverse dataset of colposcopy images from various sources and develop the AI model. The model's performance will be validated in clinical settings, assessing its accuracy in classifying cancer stages and identifying transformation zones. The impact on early detection, patient outcomes, and model usability will be evaluated, as well as its generalizability across different healthcare environments. The goal is to enhance the accuracy and efficiency of cervical cancer screening, ultimately reducing mortality rates and improving patient care.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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.

Interventions

DIAGNOSTIC_TESTColposcopy

The intervention involves the use of colposcopy, a diagnostic procedure to visually examine the cervix using a colposcope. The procedure includes the application of saline, acetic acid, and iodine solutions to enhance the visualization of cervical tissues and identify abnormalities. The dosage form includes applying these solutions directly to the cervical area. The frequency of the intervention is typically a single session per patient, with the duration of the procedure lasting approximately 10-15 minutes. This study aims to utilize an AI model to analyze the colposcopic images obtained during the procedure to improve the accuracy and efficiency of cervical cancer detection.


Locations(1)

Ibn Sina Medical College Hospital

Dhaka, Bangladesh

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NCT06644248


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