| 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
|
|
|
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
|
|
|
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. |