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CTRI Number  CTRI/2026/02/104600 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparing Urine and Cervical Swab Tests to Detect HPV Infection and Assess Cervical Cancer Risk in Women 
Scientific Title of Study   HPV Detection in Urine and Cervical Swabs: A Comparative Analysis with Oncogenic Risk Assessment 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poornisha J 
Designation  Phd Research Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)  
Address  Department of Microbiology, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9345894450  
Fax    
Email  u022401103@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sribal S  
Designation  Assistant professor  
Affiliation  Sri Ramachandra Medical College and Research Institute  
Address  Department of Microbiology, Sri Ramachandra Medical College and Research Institute, Porur

Chennai
TAMIL NADU
600116
India 
Phone  9884118630  
Fax    
Email  dr.sribal@sriramachandra.edu.in   
 
Details of Contact Person
Public Query
 
Name  Dr Sribal S  
Designation  Assistant professor  
Affiliation  Sri Ramachandra Medical College and Research Institute  
Address  Department of Microbiology, Sri Ramachandra Medical College and Research Institute, Porur

Chennai
TAMIL NADU
600116
India 
Phone  9884118630  
Fax    
Email  dr.sribal@sriramachandra.edu.in   
 
Source of Monetary or Material Support  
Founder – Chancellor Shri. N. P. V. Ramasamy Udayar Research Fellowship, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) , Ramachandra nagar, porur, Chennai, TamilNadu, India. pincode: 600116 
 
Primary Sponsor  
Name  Poornisha J 
Address  PhD Research Scholar, Department of Microbiology, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) Chennai, Porur – 600116, Contact number: 9345894450, Email: u022401103@sriramachandra.edu.in  
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sribal S  Sri Ramachandra Medical Centre and Hospital   Room no: 1A Division: Molecular Biology Centre and Clinical Virology Section Department of Microbiology, SRMC, Ramachandra Nagar, Porur. Chennai- 600116 TAMIL NADU India
Chennai
TAMIL NADU 
9884118630

dr.sribal@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Sri Ramachandra Institute of Higher Education and Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Women who come for cervical screening in the reproductive age group and elderly (aged 21-65
years)
White discharge per-vaginum
Pain in the lower abdomen
Intermenstrual bleeding
Post-menopausal bleeding
Dyspareunia
Menstrual abnormalities 
 
ExclusionCriteria 
Details  Women below 20 years of age
Women who are pregnant
Women who use local douche
Women not willing to give consent for pap smear/ HPV testing 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study could reveal the effectiveness of urine samples as a non-invasive alternative
to cervical swabs for detecting HPV and its genotypes.  
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
This Study can help in early
identification of high-risk Oncogenic cases.  
1 year 
Thia study can evaluate the
accuracy & effectiveness of Pap smears in detecting early-stage cervical cancer. This can help
improve diagnostic practices & guidelines. 
1 year 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   15/03/2026 
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="3"
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  

Cervical cancer remains a major global public health concern, ranking as the fourth most common cancer among women worldwide, with an estimated 6,60,000 new cases and 3,50,000 deaths reported in 2022. The burden falls disproportionately on low- and middle-income countries. The Southeast Asia Region reports the second-highest incidence and mortality, with India contributing more than 65% of the regional burden. In India, cervical cancer is the second most common cancer among women, yet national screening coverage remains extremely low. Persistent infection with high-risk types of Human Papillomavirus (HPV), particularly types 16 and 18, is responsible for nearly 99% of cases. Although cervical cancer is largely preventable through vaccination and early detection, gaps in awareness, access, and acceptance continue to hinder effective prevention.

The World Health Organization (WHO) has introduced a global strategy to eliminate cervical cancer, setting the 90–70–90 targets to be reached by 2030.(1) However, several challenges continue to slow this progress, including inadequate access to screening services, limited awareness about HPV and its vaccination, and the hesitation many women feel toward invasive sample collection procedures. Against this backdrop, the proposed study assumes considerable importance. By examining HPV detection in both cervical swabs and urine samples, the study seeks to explore a screening alternative that is less invasive and potentially more acceptable to women, thereby supporting broader participation in screening initiatives. The inclusion of a questionnaire to evaluate knowledge, awareness, and attitudes related to HPV infection, HPV-related cancers, and HPV vaccination among women of reproductive age is expected to shed light on prevailing knowledge gap. Additionally, correlating Pap smear cytology findings with virological HPV test results will enhance the clinical significance of the research. Together, these components support the development of accessible, evidence-based screening strategies, directly contributing to WHO elimination goals and strengthening cervical cancer prevention efforts in the current public health trend.


 
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