| CTRI Number |
CTRI/2024/08/071936 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
comparison of PAP smear and VIA for screening of cervical cancer |
|
Scientific Title of Study
|
Comparison of diagnostic value of Visual inspection with acetic acid (VIA) and PAP Smear in screening of cervical cancer. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meena Chaudhari |
| Designation |
Resident Doctor, Obstetrics and Gynecology |
| Affiliation |
Sir T. Hospital and GMC, Bhavnagar |
| Address |
Room 1, Gopnath Maternity Home, Obstetrics and Gynecology department, Sir T. hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9020393849 |
| Fax |
|
| Email |
meenachaudhari681@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Vithal |
| Designation |
Assistant professor |
| Affiliation |
Obstetrics and Gynecology department |
| Address |
Room 2, Gopnath maternity home, Obstetrics and gynecology department, sir t. hospital bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8980806068 |
| Fax |
|
| Email |
tiwariaditi085@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meena Chaudhari |
| Designation |
Resident Doctor, Obstetrics and Gynecology |
| Affiliation |
Sir T. Hospital and GMC, Bhavnagar |
| Address |
Room no 1, Gopnath Maternity Home, Obstetrics and Gynecology department, Sir T. hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9020393849 |
| Fax |
|
| Email |
meenachaudhari681@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and Sir T. hospital near district jail, Bhavanagr Pincode- 364001 Gujarat state |
|
|
Primary Sponsor
|
| Name |
Dr Meena Chaudhari |
| Address |
room no 1, Gopnath Meternity Home, Obstetrics and Gynecological Department,sir T.hospital, near district jail, Bhavnagar, Pin code- 364001, Gujarat |
| Type of Sponsor |
Other [SELF] |
|
|
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 Meena Chuadhari |
Sir T. Hospital, Bhavnagar |
room no 1, gopnath maternity home, obstetrics and gynecology department.
Bhavnagar
GUJARAT |
9023093849
meenachaudahri681@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Government Medical College, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A64||Unspecified sexually transmitted disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL
|
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
all the patient who are giving consent, icludesEarly marriage
Early pregnancy
Sexual activity at early age
Multi parity
Multiple sexual partner
Women with STI, leucorrhoea, abnormal vaginal bleeding
|
|
| ExclusionCriteria |
| Details |
Unmarried patients.
Patients with bleeding P/V and active infection at the time of examination.
Pregnant women.
Patients with vaginal pessary
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
sensitivity of VIA compare to Pap smear to identify cervical cancer in women.
|
within month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| specificity of the VIA compare to PAP smear to identify cervical cancer. |
within month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In india for the screening of the cervical neoplasia PAP smear has been used, but for PAP smear we need trained person and laboratory infrastructure and also some studies show that PAP smear has low sensitivity. VIA is simple, easy and inexpensive. so in this study we want to compare the diagnostic performance of VIA with PAP smear for the screening cervical cancer in women. After taking written informed consent, we perform PAP smear then visual inspection with acetic acid after that biopsy will be taken after that we compare diagnostic accuracy of VIA with PAP smear. |