Role of Artificial Intelligence for detection of pre-cancerous and cancerous cervical lesions

Recruiting

Conditions: Screening of pre cancerous leisons of cervix

Registration Number: CTRI/2023/02/049936

Lead Sponsor: Government Medical college and hospital Chandigarh

Brief Summary: In India, the most common cancer of the female reproductive tract is cervical cancer. Screening for cervical cancer is an effective way to prevent the morbidity and mortality associated with the disease. WHO recommends regular screening for cervical cancer for every woman above the age of 30 years for early detection of abnormal cells. SmartscopeÂ® is an Artifical Intelligence based colposcope is an effective strategy to reduce subjectivity. It is based on the principle of colposcopy and VIA-VILI examination allowing a magnified view of the cervix and vaginal colpos as well as an objective assessment of the images of the examination through artificial intelligence. A PAP smear for all sexually active women above the age of 30 will be taken following which Pre and Post VIA-VILI images will be captured using the smartscope and the results will be analyzed for the need of biopsy in case of abnormal findings in either of the two. The results will be compared with the cytology and histopathology using the latter as the reference standard.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 268

Inclusion Criteria

Sexually active women above the age of 30 (as recommended by WHO guidelines 2021).

Exclusion Criteria

Type 3 squamocolumnar junction Active bleeding per vaginum Frank growth on the cervix Post hysterectomy History of treatment of cancerous lesions Acute cervical infection or pelvic inflammatory disease (patients can be included after treatment).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the diagnostic accuracy of the SmartscopeÂ® for detection of pre-cancerous and cancerous lesions of the cervix using cytology or histopathology as the reference standard	At first visit (when smartscope used), on collection of Pap report ,on collection of cervical biopsy report

Secondary Outcome Measures

Name	Time	Method
To compare the Swede score calculated by the observer with the AI-based diagnosis keeping cytology and histopathology as the reference standard	At first visit (when smartscope used), on collection of Pap report ,on collection of cervical biopsy report

Trial Locations

Locations (1): Department of Obstetrics and Gynaecology
🇮🇳
Chandigarh, CHANDIGARH, India
Department of Obstetrics and Gynaecology
🇮🇳Chandigarh, CHANDIGARH, India
Dr Mansi Chugh
Principal investigator
7508853318
mansi.chugh97@gmail.com