| CTRI Number |
CTRI/2023/02/049936 [Registered on: 21/02/2023] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Artificial Intelligence for detection of pre-cancerous and cancerous cervical lesions |
|
Scientific Title of Study
|
Role of Artificial Intelligence-based colposcope for detection of pre-cancerous and cancerous cervical lesions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mansi Chugh |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Obstetrics and Gynaecology , B Block Level 4, ,Government Medical College and Hospital Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
|
| Fax |
|
| Email |
mansi.chugh97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Goel |
| Designation |
Professor |
| Affiliation |
Government Medical college and Hospital Sector 32 Chandigarh |
| Address |
Department Of Obstetrics and Gynaecology , B Block Level4 , Government Medical College and Hospital Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
bhartigoel14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Goel |
| Designation |
Professor |
| Affiliation |
Government Medical college and Hospital Sector 32 Chandigarh |
| Address |
Department Of Obstetrics and Gynaecology , B Block Level 4, Government Medical College and Hospital Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
bhartigoel14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology , B Block Level 4 ,Government Medical College and Hospital Chnadigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical college and hospital Chandigarh |
| Address |
Government Medical College and Hospital Sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mansi Chugh |
Department of Obstetrics and Gynaecology |
Level 2 B Block Government Medical College and Hospital Chandigarh
Chandigarh
CHANDIGARH |
7508853318
mansi.chugh97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening of pre cancerous leisons of cervix |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Sexually active women above the age of 30 (as recommended by WHO guidelines 2021) |
|
| ExclusionCriteria |
| Details |
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) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the diagnostic accuracy of the Smartscope® 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="268"
Sample Size from India="268"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. Smartscope® 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. |