| CTRI Number |
CTRI/2025/10/095914 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
AI assisted cytology screening for cervical cancer |
|
Scientific Title of Study
|
Comparative Study of AI-assisted Cervical Cancer Detection (CerviAI) vs. Liquid-based Cytology Screening |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenakshi Gothwal |
| Designation |
Additional Professor OBGYN |
| Affiliation |
AIIMS JODHPUR |
| Address |
AIIMS Jodhpur, Dept of OB-GYN, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9212126860 |
| Fax |
|
| Email |
meenakshigothwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhritiman Mallick |
| Designation |
CEO-COO |
| Affiliation |
Vyuhaa Med Data Private Limited |
| Address |
C/O CPath Labs, 5th Floor KK Plaza, Madhapur Hyderabad 500081
Hyderabad
TELANGANA
500081
India |
| Phone |
9883226847 |
| Fax |
|
| Email |
dhritiman@vyuhaadata.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sashmita Swain |
| Designation |
Professor and HoD OB-GYN |
| Affiliation |
SCB CUTTACK |
| Address |
SCB Medical College and Hospital
Behera Colony, Mangalabag, Cuttack, Odisha 753001
Cuttack
ORISSA
753001
India |
| Phone |
9861085727 |
| Fax |
|
| Email |
drsasmitaswain@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1. Vyuhaa Med Data Private Limited
Regd Office: 4/608 G1 VOC Street Perungudi OMR Chennai Neelankarai Chennai City Corporation Kanchipuram Tamil Nadu - 600041, India
2. Indian Council of Medical Research
Dr. Aparna Mukherjee
RCN & CSTU
Division of Development Research
First Floor, New Building
Indian Council of Medical Research
V. Ramalingaswami Bhawan
Ansari Nagar, New Delhi – 110029, India |
|
|
Primary Sponsor
|
| Name |
Vyuhaa Med Data Private Limited |
| Address |
4/608 G1 VOC Street Perungudi OMR Chennai Neelankarai Chennai City Corporation
Kanchipuram Tamil Nadu - 600041 |
| Type of Sponsor |
Other [Research startup] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council of Medical Research |
AIIMS Campus Temple, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dhritiman Mallick |
Department of Histopathology CPath Labs Hyderabad |
5th Floor,KK Plaza, 100 Feet Rd, Ayyappa Society, Chanda Naik Nagar, Madhapur, Hyderabad, Telangana 500081
Hyderabad
TELANGANA |
9883226847
dhritiman@vyuhaadata.com |
| Dr Sasmita Swain |
Department of Obstetrics and Gynecology and Department of Pathology |
SCB Medical College and Hospital
Behera Colony, Mangalabag, Cuttack, Odisha 753001
Cuttack
ORISSA |
9861085727
drsasmitaswain@gmail.com |
| Dr Meenakshi Gothwal |
Department of Obstetrics and Gynecology and Department of Pathology and lab medicine |
AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
9212126860
gothwalm@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SCB Medical College Hospital, Cuttack |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening and early detection of cervical cancer ICD 10 C53.9 in healthy women volunteers belonging to the target population of the intervention. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HPV testing on all positive samples |
HPV testing on all positive samples |
| Comparator Agent |
Manual testing of all liquid based cytology samples |
Manual testing of all liquid based cytology samples by a qualified pathologist |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 25-65 with no prior history of cervical cancer.
Patients within the screening age range who have undergone a supracervical hysterectomy.
Individuals over 65 years old without documented prior screening.
Vault smears are recommended for patients with a history of cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
|
|
| ExclusionCriteria |
| Details |
Pregnant women.
Women with a known history of cervical cancer or those undergoing chemotherapy/radiotherapy.
Patients who have undergone a hysterectomy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the diagnostic accuracy of CerviAI-Assisted detection of biopsy proven high-grade squamous abnormalities of the cervix (HSIL, ASC-H) as compared to manually reported LBC smears |
Index (CerviAI) and comparator (manual LBC) will be performed on the same LBC specimen at Day 0. Colposcopy and biopsy must occur within 50 days of sampling for positive cases |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of CerviAI in detecting low-grade squamous intraepithelial lesions (LSIL) and atypical squamous cells of undetermined significance (ASCUS), compared to manual LBC reporting. |
Assessed at the time of initial cervical screening and correlated with follow-up biopsy or repeat cytology/HPV triage during the 12-month study period. |
|
|
Target Sample Size
|
Total Sample Size="4400"
Sample Size from India="4400"
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)
|
01/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This multicenter prospective trial compares CerviAI, an AI-assisted cervical cancer screening system, with manual liquid-based cytology. Its primary focus is on the diagnostic accuracy of CerviAI in detecting high-grade squamous intraepithelial lesions on LBC digitised slides, with secondary attention to detection of low-grade lesions and concordance with manual reporting. A total of 4,400 women aged 25–65 will be enrolled/recruited across AIIMS Jodhpur and SCB Cuttack over 12 months. Preclinical validation demonstrated high sensitivity and specificity, and this clinical assessment aims to confirm the efficacy, safety, and scalability of CerviAI in resource-constrained settings, enabling faster, affordable, and accessible cervical cancer screening. |