| CTRI Number |
CTRI/2026/02/102856 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early detection of Vulvar precancer in women with HPV using a special examination technique |
|
Scientific Title of Study
|
Clinical utility of the three ring vulvoscopy as a screening tool for the detection of vulvar
intraepithelial neoplasia in HPV positive female |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drbharti joshi |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6281014571 |
| Fax |
|
| Email |
drbhartijoshi09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drbharti joshi |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6281014571 |
| Fax |
|
| Email |
drbhartijoshi09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drbharti joshi |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6281014571 |
| Fax |
|
| Email |
drbhartijoshi09@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGImer chandigarh, sector 12,160012,india
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
PGIMER, sector 12,Chandigarh 160012,india |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSireesha |
PGIMER |
Gynae opd,Sector 12,Chandigarh
Chandigarh
CHANDIGARH |
6281014571
Bollysireesha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee (intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C519||Malignant neoplasm of vulva, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Confirmed HPV positive status by HPV DNA testing or pap smear.
3. Patients who have not undergone vulvar surgery or ablation therapy in last 6 months.
4.Consent to participate
|
|
| ExclusionCriteria |
| Details |
1.Antenatal female.
2.Women with known vulvar carcinoma.
3.Age less than 30 years.
4.Women with recent vulvar surgery (within last 6 months) .
5.Women with active vulvar infections or severe inflammation(genital herpes or candidiasis)
6.Contraindication or allergy to acetic acid.
7.Refusal to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
evaluate effectiveness of threering Vulvoscopy in detecting VIN in HPV positive females with normal vulval examination.
Secondary objective:
|
3 weeks after tests
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate correlation between lesion, location & its association with severity of VIN lesions.
2.To find out lesions other than VIN in HPV positive females.
3.To correlate VIN with cervical cytology abnormalities.
|
4weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
18/02/2026 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is an observational study. This study evaluates the clinical utility of Three Ring Vulvoscopy technique for detecting premalignant vulvar lesions specifically in HPV-positive women. It will validate a structured scoring system incorporating symptoms,paintests,lesion appearance and ring wise localization. The findings may contribute to early detection strategies, preventive care, and screening protocols for vulvar neoplasia in asymptomatic or high-risk populations. |