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CTRI Number  CTRI/2010/091/006076 [Registered on: 20/12/2010]
Last Modified On: 25/02/2013
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study
Modification(s)  		 Follow Up Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Early detection of cervical neoplasia by visual screening and hybrid capture testing by self and physician collection methodology - A community based study in rural area  
Scientific Title of Study   Early detection of cervical neoplasia by visual screening and hybrid capture testing by self and physician collection methodology - A community based study in rural area  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEERJA BHATLA 
Designation   
Affiliation   
Address  ROOM NO. 3101
THIRD FLOOR, DEPTT. OF OBS. AND GYNAE.
New Delhi
DELHI
110029
India 
Phone  011-26594991  
Fax  +91-11-26588641  
Email  neerjabhatla@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  NEERJA BHATLA 
Designation   
Affiliation   
Address  ROOM NO. 3101
OF OBS. AND GYNAE.
New Delhi
DELHI
110029
India 
Phone  +91-11-26588641  
Fax  +91-11-26588641  
Email  neerjabhatla@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  NEERJA BHATLA 
Designation   
Affiliation   
Address  ROOM NO. 3101
OF OBS. AND GYNAE.
New Delhi
DELHI
110029
India 
Phone  +91-11-26588641  
Fax  +91-11-26588641  
Email  neerjabhatla@rediffmail.com  
 
Source of Monetary or Material Support  
Qiagen India Pvt.Ltd International Business Center, M 38/1 Middle Circle,Connaught Place, New-Delhi,110001.  
 
Primary Sponsor  
Name  Qiagen India Pvt.Ltd 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR.NEERJA BHATLA  AIIMS  ,-

 

 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Evaluate the performance of VIA,VILI, HCII testing and colposcopy in the detection of cervical cancer precursor lesions Assess feasibility and reliability of self- vs physician-collected samples 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  30.00 Year(s)
Age To  59.00 Year(s)
Gender  Female 
Details  Age > 30 years of age
Ability to give informed consent
Sexually active
No debilitating disease (physically able to undergo study procedures)
 
 
ExclusionCriteria 
Details  Women who have undergone excision biopsy, cryotherapy and conisation and hysterectomy,Acute cervicitis or vaginitis,Pregnancy Severe debilitating disease.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Detection of CIN via HPV test  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of self sampling with physician. comparison of VIA-VILI with HC2.  1 Year 
 
Target Sample Size
Modification(s)  		 Total Sample Size="1000"
Sample Size from India="1000" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/01/2011 
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 Yet Recruiting 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Naked eye visual inspection of the cervix after application of acetic acid (VIA) and HPV testing are alternative methods for cervical cancer screening in low resource settings for reducing the burden of the disease. The high sensitivity and low specificity of VIA results in high referral rates. HPV testing has been shown to be a better screening test than Pap smear and is now being recommended as the method of primary screening for cervical cancer. However, it still suffers from some of the drawbacks of Pap smear. The requirement for a health care provider to collect the samples and many logistic requirements at the periphery, such as examination facilities, sterile speculums, light source, etc., still remain. Self-sampling has shown to have 94% concordance with cervical sampling in our pilot study and was found to have good acceptability among Indian women. The aim of this study is to assess the feasibility and reliability of this method in the community setting, as a model for cervical cancer screening at the primary health centres and sub-centres.  
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