Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644248
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
AI Model for Cervical Cancer Detection From Colposcopy Images
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Evaluation of an Artificial Intelligence Model for Cervical Cancer Detection From Colposcopic Images
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 models 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
Detailed Description:
The study aims to develop an AI model to improve cervical cancer screening by analyzing colposcopic images The study is a prospective and retrospective case-control study conducted at Ibn Sina Medical College Hospital in Dhaka Bangladesh The primary goal is to leverage deep learning techniques to enhance the accuracy and efficiency of cervical cancer detection particularly in low-resource settings Cervical cancer remains a significant health challenge particularly in low- and middle-income countries where access to timely screening and treatment is limited Colposcopy is a diagnostic procedure used to examine the cervix for signs of disease Traditional colposcopy is highly dependent on the clinicians experience leading to subjectivity and potential inaccuracies This research proposes using AI to automate the analysis of colposcopic images aiming to provide a more objective and reliable diagnostic tool The primary objectives are to curate a comprehensive dataset of colposcopy images and develop an AI model capable of accurately classifying transformation zones and detecting cervical abnormalities Specific objectives include clinical validation of the AI models performance assessing the models usability in clinical workflows evaluating the impact of the AI model on early detection of cervical cancer ensuring the models generalizability across diverse datasets and investigating the models effectiveness as a clinical decision support tool Inaccuracies in traditional vision screening and a shortage of trained personnel in low-resource settings hinder effective cervical cancer screening The AI model aims to mitigate these issues by providing an automated scalable and cost-effective solution By improving the accuracy and accessibility of cervical cancer screening this research has the potential to significantly impact patient outcomes in resource-limited environments The study involves both prospective and retrospective data collection Colposcopic images and relevant clinical metadata will be gathered from patients at the study sites The data will be used to train and validate the AI model Inclusion criteria for the study are women aged 18 or older who are willing to participate in cervical cancer screening and have no history of hysterectomy Exclusion criteria include pregnant women and individuals with severe medical conditions that could affect screening results The target population includes confirmed cervical cancer patients and individuals with suspected cervical abnormalities Data from individuals with normal cervical conditions will also be included to facilitate unsupervised learning Sample size calculations will follow established methodologies for evaluating diagnostic performance considering factors such as sensitivity specificity and disease prevalence The study includes several quality assurance measures to ensure data accuracy and reliability A quality assurance plan addresses data validation and registry procedures including site monitoring and auditing Data checks will compare registry entries against predefined rules for range and consistency Source data verification will be conducted by comparing registry data with external sources such as medical records Standard Operating Procedures SOPs will cover registry operations including patient recruitment data collection data management data analysis adverse event reporting and change management Sample size assessment specifies the number of participants required to demonstrate the models effectiveness A plan for addressing missing data includes strategies for handling unavailable or inconsistent data The statistical analysis plan outlines the methods for evaluating the AI models performance including sensitivity specificity and accuracy metrics The analysis will also consider the models generalizability across different datasets and its impact on clinical decision-making and patient outcomes This research seeks to develop an AI-based solution to improve cervical cancer screening accuracy and accessibility particularly in low-resource settings By addressing the limitations of traditional colposcopy and leveraging advanced computational techniques the study aims to provide a scalable and effective tool for early detection of cervical cancer ultimately improving patient outcomes and reducing mortality rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None