| CTRI Number |
CTRI/2020/08/027023 [Registered on: 07/08/2020] Trial Registered Prospectively |
| Last Modified On: |
11/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Screening methods of cervical cancer- A comparative analysis |
|
Scientific Title of Study
|
A comparative analysis of visual inspection with acetic acid, cervical cytology and histopathology in screening and early detection of carcinoma cervix |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Japhia David |
| Designation |
PG student |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of obstetrics and gynaecology,
Gajra Raja Medical College,
J.A.H Campus,
Lashkar, Gwalior.
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
8667367291 |
| Fax |
|
| Email |
japhia29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vrunda Joshi |
| Designation |
Professor |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of obstetrics and gynaecology,
Gajra Raja Medical college,
J.A.H Campus, Lashkar, Gwalior.
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
9425112132 |
| Fax |
|
| Email |
vrundajoshi45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Japhia David |
| Designation |
PG student |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of obstetrics and gynaecology,
Gajra Raja Medical College,
J.A.H Campus, Lashkar, Gwalior.
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
8667367291 |
| Fax |
|
| Email |
japhia29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology,
Gajra Raja Medical college,
J.A.H Campus,
Lashkar,
Gwalior-474001 |
|
|
Primary Sponsor
|
| Name |
Gajra Raja Medical College |
| Address |
J.A.H campus, Lashkar, Gwalior-474001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Japhia David |
Gajra Raja Medical College |
Department of obstetrics and gynaecology,
J.A.H Campus,
Lashkar,
Gwalior- 474001
Gwalior
MADHYA PRADESH |
8667367291
japhia29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
All sexually active women and women in reproductive age group with recurrent episodes of white discharge, postcoital bleeding and intermenstrual bleeding. |
|
| ExclusionCriteria |
| Details |
Women who refused to give consent and known cases of cervical carcinoma, pregnant women, women with active vaginal bleeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| For women who are devoid of any screening test, VIA based screenng will be a good screening tool. |
At the end of the study (i.e, 1 year) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate the sensitivity and specificity of VIA screeing of carcinoma cervix. |
At the end of the study (i.e, 1 year) |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/08/2020 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
500 patients who meet the inclusion criteria are chosen. After taking proper history and consent, the women is subjected to cervical cytology. The cytology is studied and reported by Bethesda system. Then the women is subjected to visual inspection the acetic acid. If sharp well defined acetowhite areas touching squamocoloumnar junction are found, they are considered positive and subjected to histopathology. Then a comparative analysis of cervical cytology, visual inspection with acetic acid and histopathology is done. |