| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|