| CTRI Number |
CTRI/2025/12/099951 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How tests like p16, Ki-67, and HPV help doctors to detect and understand early cell changes in the cervix that could lead to cancer. |
|
Scientific Title of Study
|
Role Of p16 and Ki-67 Immunocytochemistry along with HPV testing in Cervical Epithelial Abnormalities |
| 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 Prachi Prajapati |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.54,Department of Pathology,Pathology block,Maulana Azad Medical College,2 Bahadur Shah Zafar Marg,Central Delhi
New Delhi
DELHI
110002
India |
| Phone |
8178535024 |
| Fax |
|
| Email |
7.153.prachiprajapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Verma |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.54,Department of Pathology,Pathology block,Maulana Azad Medical College,2 Bahadur Shah Zafar Marg,Central Delhi
New Delhi
DELHI
110002
India |
| Phone |
8527271104 |
| Fax |
|
| Email |
drnidhikamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Verma |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.54,Department of Pathology,Pathology block,Maulana Azad Medical College,2 Bahadur Shah Zafar Marg,Central Delhi
New Delhi
DELHI
110002
India |
| Phone |
8527271104 |
| Fax |
|
| Email |
drnidhikamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,2 Bahadur shah zafar marg,new delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2,Bahadur Shah Zafar Marg ,New 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 Nidhi Verma |
Maulana Azad Medical College |
Room no.54,Department of Pathology,Pathology block,Maulana Azad Medical College,2 Bahadur Shah Zafar Marg,Central Delhi
New Delhi
DELHI |
08527271104
drnidhikamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated hospital (Lok Nayak,G.I.P.M.E.R.,Guru Nanak Eye Centre,New Delhi-110002) |
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: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Newly diagnosed cases of cervical epithelial abnormalities. |
|
| ExclusionCriteria |
| Details |
Cases of cervical infections and inflammatory lesions.Recurrent cases of cervical epithelial abnormalities.Age less than 21 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main goal is to find out how accurately p16 Ki-67 and HPV testing can help detect and confirm early changes or abnormal changes of cancer of cervix when compared to standard histopathological examination |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| p16 and Ki-67 expression and HPV testing in different categories of cervical epithelial abnormalities as per The Bethseda System. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/01/2026 |
| 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="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
|
Cervical cancer is a common cancer among women in India, and early detection through screening can greatly reduce deaths. However, routine screening tests like Pap smear and HPV testing have limitations and may lead to unnecessary biopsies. This study aims to evaluate the role of additional biomarkers, p16 and Ki-67, using immunocytochemistry along with HPV testing, in detecting cervical epithelial abnormalities. Since p16 indicates HPV-related cell changes and Ki-67 shows cell proliferation, their combined use may improve diagnostic accuracy. The results will be correlated with histopathology, which is considered the gold standard. Purpose:The purpose of this study is to find out whether p16 and Ki-67 tests, when used along with HPV testing, can improve the diagnosis of cervical epithelial abnormalities. This will help in better identification of serious lesions, reduce unnecessary biopsies, and improve patient management. |