| CTRI Number |
CTRI/2025/07/091580 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Occurrence of Human Papillomavirus genetic types in patients with eye surface tumours and its association with other sites. |
|
Scientific Title of Study
|
Frequency of Human Papillomavirus genotypes in Ocular Surface Squamous Neoplasia and its association with other mucosal sites. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reva Tak |
| Designation |
Postgraduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.39, Pathology Block
Department of Microbiology
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8494098148 |
| Fax |
|
| Email |
drrevatak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Manchanda |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.41, Pathology Block
Department of Microbiology
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604387 |
| Fax |
|
| Email |
micromamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Manchanda |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.41, Pathology Block
Department of Microbiology
Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604387 |
| Fax |
|
| Email |
micromamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,Bahadur shah Zafar Marg, near Delhi gate ,Delhi-110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, near Delhi Gate, Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Reva Tak |
Maulana Azad Medical College |
Room no. 41, Pathology Block
Department of Microbiology
Maulana Azad Medical College
Central
DELHI |
8494098148
drrevatak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C690||Malignant neoplasm of conjunctiva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All the patients above 18 years visiting Guru Nanak Eye Centre with clinical suspicion of ocular surface squamous neoplasia ( conjunctival/corneal lesions) will be included in the study. |
|
| ExclusionCriteria |
| Details |
The patients where the ocular surface squamous neoplasia is not confirmed in pathological findings will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of Human Papillomavirus genotypes in patients diagnosed with Ocular surface squamous neoplasia |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between HPV genotypes at different mucosal sites ( ocular-oral and ocular-genital HPV co-infections ) |
One year |
| Association of factors related to OSSN and HPV infection will be assessed |
One year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
07/08/2025 |
| 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="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
|
The study entitled- “Frequency of Human Papillomavirus genotypes in Ocular surface squamous neoplasia and its association with other mucosal sites” will be conducted in the Department of Microbiology, in collaboration with Department of Ophthalmology and Department of Pathology, Maulana Azad Medical College and associated hospitals. Corneal/conjunctival scrapings will be collected from all patients suspected of OSSN as a part of their routine diagnosis and clinical indication. Additional samples, including the conjunctival swab, urine sample and oral rinse sample will be obtained after taking the consent , which will undergo HPV detection and genotyping using Real-Time PCR. Data pertaining to demographic profile, presenting complaints, past history, previous treatment history and associated risk factors would be captured using a structured questionnaire This study aims to elucidate HPV’s role in OSSN causation and its association with other mucosal site HPV infections. |