| CTRI Number |
CTRI/2021/03/032167 [Registered on: 19/03/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL |
| Study Design |
Other |
|
Public Title of Study
|
cervical cancer screening using two methods i.e.Pap smear and visual inspection with acetic acid in a tertiary medical college |
|
Scientific Title of Study
|
Operationalizing cervical cancer screening using pap smear and visual inspection with acetic acid in a tertiary care hospital in East India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indira Palo |
| Designation |
Asst Professor |
| Affiliation |
Dept of Obstetric Gynecology |
| Address |
Dept of Obstetric Gynecology
M K C G Medical College Hospital
Berhampur
Odisha
Ganjam
ORISSA
760004
India |
| Phone |
|
| Fax |
|
| Email |
palo.indira@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHweta |
| Designation |
PG STUDENT |
| Affiliation |
Dept of Obstetric Gynecology |
| Address |
Dept of Obstetric Gynecology
M K C G Medical College Hospital
Berhampur
Odisha
Ganjam
ORISSA
760004
India |
| Phone |
|
| Fax |
|
| Email |
SHWETA.M94@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indira Palo |
| Designation |
Asst Professor |
| Affiliation |
Dept of Obstetric Gynecology |
| Address |
Dept of Obstetric Gynecology
M K C G Medical College Hospital
Berhampur
Odisha
Ganjam
ORISSA
760004
India |
| Phone |
|
| Fax |
|
| Email |
palo.indira@gmail.com |
|
|
Source of Monetary or Material Support
|
| VIA TEST KIT, DALRADA HEALTH, ESCONDIDO, SAN DIEGO , USA |
|
|
Primary Sponsor
|
| Name |
Dept of Obstetrics and Gynecology M K C G Medical College |
| Address |
Dept of Obstetrics and Gynecology
M.K.C.G. Medical College Hospital
Brahmapur, Odisha
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Westchester KnowledgeWorks |
Level 8, Tower 1, Umiya Business Bay, Cessna Business Park, Kadubeesanahalli Marathahalli, Bangalore, Karnataka, India, 560037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Indira Palo |
M K C G Medical College Hospital |
Dept of Obstetrics and Gynecology
Ganjam
ORISSA |
9437217544
palo.indira@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee MKCG MEDICAL COLLEGE |
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.Female subjects aged between 30-65 years
2.Sexually exposed
3.Not hysterectomized
4.Clearly visible cervix
5.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
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
12WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To obtain feedback on VIA based kit testing in the existing healthcare infrastructure. |
3MONTHS |
|
|
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)
|
24/03/2021 |
| Date of Study Completion (India) |
01/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
TBD |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The clinical investigation is designed as an 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. |