| CTRI Number |
CTRI/2026/04/107858 [Registered on: 08/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Association Between Human Papillomavirus Infection and Breast Cancer Among Women: A Case Control Study |
|
Scientific Title of Study
|
The association of human papilloma virus with carcinoma breast A case control study |
| 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 Vikas Goyal |
| Designation |
Associate professor, Dept of general surgery, GMC and RH, Patiala |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab
GMC and Rajindra hospital,Patiala, Sangrur road, Patiala.
Patiala
PUNJAB
147001
India |
| Phone |
9988392927 |
| Fax |
|
| Email |
drvikasgoyal2006@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Goyal |
| Designation |
Associate professor, Dept of general surgery, GMC and RH, Patiala |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab
GMC and Rajindra hospital,Patiala, Sangrur road, Patiala.
Patiala
PUNJAB
147001
India |
| Phone |
9988392927 |
| Fax |
|
| Email |
drvikasgoyal2006@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Goyal |
| Designation |
Associate professor, Dept of general surgery, GMC and RH, Patiala |
| Affiliation |
Government Medical College, Patiala |
| Address |
Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab
GMC and Rajindra hospital,Patiala, Sangrur road, Patiala.
Patiala
PUNJAB
147001
India |
| Phone |
9988392927 |
| Fax |
|
| Email |
drvikasgoyal2006@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DHR |
| Address |
Government of India |
| 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 Vikas Goyal |
Government Medical College and Rajindra hospital, Patiala |
Surgery Unit 7, Emergency 2nd floor, Department of General Surgery, Government medical college, Patiala, Punjab
Patiala
PUNJAB |
9988392927
drvikasgoyal2006@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Women with proved histopathological carcinoma breast
willing to participate in study |
|
| ExclusionCriteria |
| Details |
Patients already on chemotherapy/Radiotherapy
Pregnancy
Systemic inflammatory/Autoimmune disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is expected to provide region-specific evidence regarding the presence and role of HPV in breast cancer, which may contribute to understanding breast carcinogenesis and future preventive strategies. |
The study is expected to provide region-specific evidence regarding the presence and role of HPV in breast cancer, which may contribute to understanding breast carcinogenesis and future preventive strategies. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If association is proven then role of vaccination against human papilloma virus in decreasing the incidence of carcinoma breast can be studied |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
20/04/2026 |
| 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="2"
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
|
This study aims to evaluate the association between Human Papilloma Virus infection and carcinoma breast through a case control design at Government Medical College Patiala over a period of two years. Breast cancer is one of the leading causes of cancer related mortality among women and while HPV is a well established cause of cervical and other anogenital cancers its role in breast cancer remains controversial especially in India where limited data are available. The study will include 64 histopathologically confirmed breast cancer patients as cases and 64 patients with benign breast disease or normal breast tissue as controls making a total of 128 participants. Paraffin embedded or fresh frozen tissue samples will be analyzed for the presence of HPV DNA using PCR and IHC techniques. HPV positive samples will be further genotyped for types 16 18 and 33. The primary objectives are to detect HPV DNA in breast cancer tissue and to evaluate its association with breast cancer development. The secondary objective is to compare HPV prevalence between malignant benign and normal breast tissue. Ethical approval and informed consent will be obtained and confidentiality will be maintained. The study is expected to provide region specific evidence regarding the possible role of HPV in breast carcinogenesis and may contribute to better understanding and future preventive strategies.
|