FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/09/003986 [Registered on: 16/09/2013] Trial Registered Retrospectively
Last Modified On: 15/01/2014
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   HPV prevalence and type distribution in cervical infection, cervical intraepithelial lesions and cervical cancer in Indian Women 
Scientific Title of Study   Prevalence, Genotype Distribution of HPV in Cervical Infection, and attribution of HPV types to Cervical Intraepithelial Neoplasia and Cervical Cancer in Indian Women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abraham Peedicayil 
Designation  Professor and Head, Dept of Obstetrics & Gynecology 
Affiliation  Christian Medical College, Vellore 
Address  Christian Medical College Hospital, Ida Scuddar Road, Vellore - 632004, Tamilnadu India

Vellore
TAMIL NADU
632004
India 
Phone    
Fax    
Email  abraham@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandeep Singh Dhingra 
Designation  Chief Clinical Officer and Head Clinical R&D 
Affiliation  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, #5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  040-66301000  
Fax  040-23234133  
Email  DrMandeep@shanthabiotech.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Mandeep Singh Dhingra 
Designation  Chief Clinical Officer and Head Clinical R&D 
Affiliation  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, #5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad

Hyderabad
ANDHRA PRADESH
500004
India 
Phone  040-66301000  
Fax  040-23234133  
Email  DrMandeep@shanthabiotech.co.in  
 
Source of Monetary or Material Support  
Shantha Biotechnics Limited 
 
Primary Sponsor  
Name  Shantha Biotechnics Limited 
Address  Shantha Biotechnics Limited, 3rd and 4th Floor, Vasantha Chambers, #5-10-173, Fateh Maidan Road, Basheer Bagh, Hyderabad-500004, AP, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Partha Basu  Department of Gynecological Oncology, Chittaranjan National Cancer Institute  Chittaranjan National Cancer Institute 37, S. P. Mukherjee Road Kolkata-700026
Kolkata
WEST BENGAL 		 91-9331034069
91-3324851558
basupartha@hotmail.com 
Dr Neerja Bhatla  Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences  Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences, New Delhi -110029
New Delhi
DELHI 		 91-11-26594991

neerja.bhatla07@gmail.com 
Dr Abraham Peedicayil  Department of Obstetrics and Gynecology, Christian Medical College, Vellore  Christian Medical College Hospital, Ida Scuddar Road, Vellore-632004
Vellore
TAMIL NADU 		 91-4162283395
91-4162232035
abraham@cmcvellore.ac.in 
Dr Usha Rani Poli  MNJ Institute of Oncology & Regional cancer center  Red Hills, Hyderabad, A.P, India-500004
Hyderabad
ANDHRA PRADESH 		 9849469296

ushapoli@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS  Approved 
Institutional Ethics Committee, Chittaranjan National Cancer Institute  Approved 
Institutional Ethics Committee, MNJ Institute of Oncology & Regional Cancer Centre, Hyderabad  Approved 
Institutional Review Board, Christian Medical College, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  HPV infection, Cervical intraepithelial neoplasia and Cervical cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  • Adult women aged 18 – 60 years,
• With or without history of cervical intraepithelial neoplasia lesion or Cervical cancer;
• Willing to give Informed consent
 
 
ExclusionCriteria 
Details  • Subject is pregnant
• Previous vaccination against HPV
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of specific HPV types for each cervical pathology status   Upon subject enrollment in the study (visit 1; single time point)  
 
Secondary Outcome  
Outcome  TimePoints 
Attribution rates of specific HPV types for each cervical pathology status   Upon subject enrollment in the study(visit 1; single time point) 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   27/06/2013 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

A multicenter prospective surveillance study in Indian women to estimate the prevalence of HPV infection and genotype distribution in Cervical infection, Cervical Intraepithelial Neoplasia (CIN) and Cervical cancer. The study will be conducted in approximately 2000 adult women aged 18 – 60 years visiting Gynecology outpatient departments at hospitals and community centres across India. Cervical samples will be collected from all the subjects and sent to the lab for cervical cytology and HPV DNA testing.

 
Close