| CTRI Number |
CTRI/2025/08/093193 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To identify and study the most common high-risk HPV genotypes present among women in the Kumaon region. The study findings are crucial for developing targeted prevention and intervention strategies to improve womens health outcomes in the area. |
|
Scientific Title of Study
|
Study on prevalence of Human Papillomavirus (HPV) and distribution of specific high risk genotypes of HPV among women of Kumaon |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Somesh Mehra |
| Designation |
Research Scientist II (Scientist C) |
| Affiliation |
Multidisciplinary Research Unit (MRU), Government Medical College Haldwani |
| Address |
Multidisciplinary Research Unit (MRU), 2nd Floor Pathology Building, Government Medical College, Rampur Road, Haldwani 263139 U.K.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9410431774 |
| Fax |
|
| Email |
drsomeshmehra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Somesh Mehra |
| Designation |
Research Scientist II (Scientist C) |
| Affiliation |
Multidisciplinary Research Unit (MRU), Government Medical College Haldwani |
| Address |
Multidisciplinary Research Unit (MRU), 2nd Floor Pathology Building, Government Medical College, Rampur Road, Haldwani 263139 U.K.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9410431774 |
| Fax |
|
| Email |
drsomeshmehra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Somesh Mehra |
| Designation |
Research Scientist II (Scientist C) |
| Affiliation |
Multidisciplinary Research Unit (MRU), Government Medical College Haldwani |
| Address |
Multidisciplinary Research Unit (MRU), 2nd Floor Pathology Building, Government Medical College, Rampur Road, Haldwani 263139 U.K.
Nainital
UTTARANCHAL
263139
India |
| Phone |
9410431774 |
| Fax |
|
| Email |
drsomeshmehra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Health Research (DHR-ICMR)
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - PIN: 110001. India |
|
|
Primary Sponsor
|
| Name |
Department Of Health Research (DHR-ICMR) |
| Address |
Department of Health Research (DHR),
Ministry of Health and Family Welfare
2nd Floor IRCS Building, 1-Red Cross Road
New Delhi 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Godawari Joshi |
Dr. Susheela Tiwari Government Hospital, Government Medical College, Haldwani |
OPD Gynaecology,
Department of Obstetrics & Gynaecology,
Dr. Susheela Tiwari Government Hospital,
Rampur Road, Haldwani (Nainital – 263129) Uttarakhand.
Nainital
UTTARANCHAL |
9412306588
godawarij14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Haldwani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N879||Dysplasia of cervix uteri, unspecified, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Married woman of 21 years or above,
2. Patients presenting with complaints of Excessive or abnormal discharge per vagina
3. Irregular or abnormal Bleeding per vagina spotting
4. Pain during coitus
5. Post coital bleeding
6. Lower abdominal pain
7. Cervix bleeds on touch
8. Unhealthy cervix on per speculum examination
9. Patient without any complaint
10. Belong to North India (by descent)
11. Giving informed consent |
|
| ExclusionCriteria |
| Details |
1. Unmarried women
2. Pregnant women
3. Age less then 21 years
4. Not giving informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will provide the burden of unhealthy cervix, with or without cervical dysplasia, along with pattern of HPV type in the region that will pave the way for tailor made policy for cervical cancer screening, HPV vaccination, management of cases. |
36 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)
The study will provide estimate of unhealthy cervix conditions on female patients which will facilitate the identification of risk factors & the implementation of effective screening strategies, thereby enhancing early detection & treatment options within the healthcare system. |
30 months |
b)
The findings related to the distribution & characterization of various high-risk HPV genotypes, including among the targeted demographic group. |
36 months |
c)
Different local geographical area-based HPV prevalence identification in add-on to major high
-risk genotyping may aid identification of hot-spot areas of HPV infection/prevalence. |
36 months |
d)
The result will establish a specific pattern of HPV types prevalent in the region, which will facilitate the development of customized policies for cervical cancer screening & HPV vaccination initiatives. |
36 months |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
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)
|
25/08/2025 |
| 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="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
Modification(s)
|
This study aims to provide a comprehensive understanding of the HPV genotype landscape in this demographic region, which is crucial for informing public health initiatives and clinical practices. By analyzing the data gathered from this study, the future plan will focus on implementing targeted interventions and educational programs aimed at reducing the incidence of HPV-related cervical diseases. In this study, in addition to the tertiary care hospital, the samples will also be collected from different district of Kumaon region. The insights gained regarding the prevalence and genotype distribution will guide healthcare providers in developing tailored screening and vaccination strategies, ultimately contributing to improved health outcomes for women in the region. Ultimately, the insights gained from this study could play a pivotal role in shaping health policies and educational programs aimed at improving cervical health outcomes for women in Uttarakhand and beyond. |