| CTRI Number |
CTRI/2019/12/022261 [Registered on: 05/12/2019] Trial Registered Prospectively |
| Last Modified On: |
22/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
open label |
| Study Design |
Other |
|
Public Title of Study
|
Comparision of two methods of cervical cancer screening i.e. cell based method(papsmear) and naked eye examination after applying like vinegar(VIA). |
|
Scientific Title of Study
|
Cervical cancer screening using pap smear and visual inspection with acetic acid in a tertiary care hospital in South India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KIMS IEC/S17-2019 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PAYAL KESWARPU |
| Designation |
DIRECTOR &CMO |
| Affiliation |
DIRECTOR |
| Address |
Umiya Business Bay Tower 1, Level 8
Embassy Tech Square Main Rd
Bangalore
KARNATAKA
560103
India |
| Phone |
|
| Fax |
|
| Email |
payal@westchesterlabs.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PAYAL KESWARPU |
| Designation |
DIRECTOR & CMO |
| Affiliation |
DIRECTOR |
| Address |
Umiya Business Bay Tower 1, Level 8
Embassy Tech Square Main Rd
Bangalore
KARNATAKA
560103
India |
| Phone |
|
| Fax |
|
| Email |
payal@westchesterlabs.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PAYAL KESWARPU |
| Designation |
DIRECTOR & CMO |
| Affiliation |
DIRECTOR |
| Address |
Umiya Business Bay Tower 1, Level 8
Embassy Tech Square Main Rd
Bangalore
KARNATAKA
560103
India |
| Phone |
|
| Fax |
|
| Email |
payal@westchesterlabs.com |
|
|
Source of Monetary or Material Support
|
| DALRADA HEALTH PRODUCTS INC
600 La Terraza Blvd, Escondido, CA |
|
|
Primary Sponsor
|
| Name |
WESTCHESTER KNOWLEDGEWORKS PVT LTD |
| Address |
Level 8, Tower 1, Umiya Business Bay, Cessna Business Park, Kadubeesanahalli Marathahalli, Bangalore, Karnataka, India, 560037 |
| Type of Sponsor |
Other [PVT LTD] |
|
|
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 Hethyshi Ranganna |
Kempegowda Institute of Medical Sciences |
Department of OBG, KIMS, V. V. Puram
Bangalore
KARNATAKA |
9535592250
hethyshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUIONAL ETHICS COMMITTEE, KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cervical Cancer Screening |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Sexually exposed
2.Not hysterectomized
3.Clearly visible cervix
4.Willing to sign consent form
|
|
| ExclusionCriteria |
| Details |
1.Consent not available
2.Age <30 years
3.Sexually unexposed
4.No cervix/ cervix not visible
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To get an understanding on conducting cervical cancer screening in outpatient center by Gynecologist using naked eye VIA based method. And compare the results of VIA based detection with Pap smear results. |
To get an understanding on conducting cervical cancer screening in outpatient center by Gynecologist using naked eye VIA based method. And compare the results of VIA based detection with Pap smear results. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To obtain feedback on VIA based kit testing in the existing healthcare infrastructure. The feedback of doctors at OPD setting will be recorded using questionnaire. |
100 completed |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2019 |
| Date of Study Completion (India) |
19/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
To be done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The clinical investigation will be designed as observational study, because it is being conducted primarily to understand the implementation of VIA based screening in outpatient setting. Women who satisfy the inclusion criteria and are willing to sign the consent form will be enrolled for the study. PI will recruit the female subjects and will examine them as per routine protocol for cervical cancer screening in the hospital. In addition, they will perform visual inspection with acetic acid. Subject’s brief history and examination findings will be recorded in CRF. Pap smear results for each case will be collected when ready and results entered in the CRF. Cervical biopsy will be done for screening positive patients. At the end of the study the results will be compiled for all the cases and analysis will be done.
Combining VIA and Pap tests will reduce the number of visits to the hospital, as biopsy can be immediately taken in VIA positive case. In our study we used a ready-to use “kit†instead of preparing 5% acetic acid solution, and procuring each item like glove, speculum etc. separately. This was helpful as we always had the necessary items instead of waiting for availability of 5% acetic acid solution.
|