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CTRI Number  CTRI/2013/02/003353 [Registered on: 06/02/2013] Trial Registered Retrospectively
Last Modified On: 04/10/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Pilot Study to know whether menstrual pad/cloth can be a cervical cancer screening tool 
Scientific Title of Study   Evaluation of self sampling method using the menstrual sanitary devices to detect high risk Human Pailloma Virus to simplify cervical cancer screening in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 1004 (TMC-IRB)  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atul Budukh 
Designation  Assistant Professor Epidemiology 
Affiliation  Tata Memorial Centre Mumbai 
Address  Centre For Cancer Epidemiology Room No 615 Annex Building Tata Memorial Centre E Borges Marg Parel Mumbai Maharashtra
Centre For Cancer Epidemiology Room N0 615 Annex Building Tata Memorial Centre E Borges Marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  09920863064  
Fax    
Email  atul.budukh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Atul Budukh 
Designation  Assistant Professor Epidemiology 
Affiliation  Tata Memorial Centre Mumbai 
Address  Centre For Cancer Epidemiology Room No 615 Annex Building Tata Memorial Centre E Borges Marg Parel Mumbai Maharashtra
Centre For Cancer Epidemiology Room N0 615 Annex Building Tata Memorial Centre E Borges Marg Parel Mumbai

MAHARASHTRA
400012
India 
Phone  09920863064  
Fax    
Email  atul.budukh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Atul Budukh 
Designation  Assistant Professor Epidemiology 
Affiliation  Tata Memorial Centre Mumbai 
Address  Centre For Cancer Epidemiology Room No 615 Annex Building Tata Memorial Centre E Borges Marg Parel Mumbai Maharashtra
Centre For Cancer Epidemiology Room N0 615 Annex Building Tata Memorial Centre E Borges Marg Parel Mumbai

MAHARASHTRA
400012
India 
Phone  09920863064  
Fax    
Email  atul.budukh@gmail.com  
 
Source of Monetary or Material Support  
Ministry of Science and Technology Department of Biotechnology Government Of India  
 
Primary Sponsor  
Name  Ministry of Science and Technology 
Address  Department of Biotechnology Government of India Bloc 2, 6-8 th Floors CGO Complex , Lodhi Road New Delhi - 110 003 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
NS Panse  Rural Cancer Registry Barshi  Department of Cancer Registry II nd Flood Nargis Dutt Memorial Cancer Hospital, Agalgaon Road
Solapur
MAHARASHTRA 
9545033237

nspanse@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IRB Tata Memorial Centre Mumbai  Approved 
NDMCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy married women age 30 to 50 with no history of cervical cancer Unmarried girl 12 to 18 having regular menstruation 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Day(s)
Age To  50.00 Day(s)
Gender  Female 
Details  Healthy married women of age 30 to 50 and permanent residence of nearby area of Jamkhed will be consider as eligible
A unmarried daughter mother pair will be included. An unmarried healthy daughter who has started to menstruate (12 to 18)will be included in the study  
 
ExclusionCriteria 
Details  Those women have history of precancer or cancer or who had total hysterectomy will be excluded. Women who are pregnant will be excluded 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Acceptance of women to provide a menstrual pad as a cervical cancer screening tool

Concordance of HPV testing by PCR and HC2

Senistivity and specificity of the test 
In six months from the enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
Develop standard method for detecting HPV in menstrual pad by PCR

Determine if there are any non sexual transmission of HPV to teenage and adolescent girls from their mother due to contamination of homemade napkins 
After 8 months
 
 
Target Sample Size   Total Sample Size="1250"
Sample Size from India="1250" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In this study we would like to find out whether menstrual pads/napkin can be used as a cervical cancer screening tool.  The objective of the study is to test the DNA extraction from the menstrual pads is good enough in quality and quantity for HPV testing by PCR technique. The consented women will be requested to provide the sanitary pads/clothes that will be transported to a central lab where a PCR based testing will be done for the presence of high risk HPV. These women will be screened by Hybrid Capture-2 method and the concordance of the two tests will be determined. Pilot study will be conducted in 200 women of age group 30 to 50. The HPV positive either by HC2/PCR will be further investigated or treated at NDMCH, Barshi.

After the pilot study, we will conduct a population based screening study in 1000 women in a rural community near Barshi -Jamkhed in Maharashtra state. Trained female social workers will counsel, educate and will conduct the interview of all consenting women aged 30 to 50 years. The social workers will collect the used sanitary pads or similar devices (clothes) from the women. Theses pads will be processed, packed and transported to a central facility at National Institute for Research in Reproductive Health (NIRRH), ICMR, Mumbai. After extracting the genetic material it will be tested by PCR methodology for the presence of HPV.  Based on the previus study we assume 10% of this sample will be test positive for HPV. Based on the test reports a set of cases (HPV positive based on PCR) and controls (HPV negative based on PCR) will be recalled for further investigation including VIA and or Colposcopy during which a cervical sample will be collected for HPV testing using HC2 technology. Those with precancerous lesions or cancer will be treated at Nargis Dutt Memorial Cancer Hospital, Barshi. If successful this approach can help to overcome the practical challenges in implementing a HPV based cervical cancer screening programme in our community. This will also demonstrate the feasibility of integrating this method into the public health programme such as National Rural Health Mission

The IARC monograph on HPV states that there are number of studies reporting that HPV might occasionally be transmitted through modes other than sexual activity. To evaluate this aspect, we will perform a parallel study and enroll 50 mother and unmarried daughter pair to determine the possibility of cross infection by HPV due to reuse of homemade sanitary napkins. This study will also provide information on the prevalence of HPV in the menstrual pads of adolescent girls and the role of any horizontal transmission of HPV due to poor hygiene practices such as reused sanitary pads.



 
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