| CTRI Number |
CTRI/2023/06/053889 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
To compare two methods of cervical cancer screening i.e, Conventional pap smear and liquid based cytology |
|
Scientific Title of Study
|
Comparison of conventional PAP smear and liquid based cytology for cervical cancer screening |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinutha V |
| Designation |
OBG JR 2 |
| Affiliation |
VIMS Ballari |
| Address |
VIMS Ballari
No.36/1,12th cross,manjunatha layout ,basavanapura main road ,k r puram ,bangalore36
Bellary
KARNATAKA
583104
India |
| Phone |
8553772905 |
| Fax |
|
| Email |
vinuthav65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usharani N |
| Designation |
Associate professor |
| Affiliation |
VIMS Ballari |
| Address |
VIMS Ballari
VIMS Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9739678554 |
| Fax |
|
| Email |
ushadrrani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinutha V |
| Designation |
OBG JR 2 |
| Affiliation |
VIMS Ballari |
| Address |
No.36/1,12th cross,manjunatha layout ,basavanapura main road ,k r puram ,bangalore36
Bellary
KARNATAKA
560036
India |
| Phone |
8553772905 |
| Fax |
|
| Email |
vinuthav65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijayanagar institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Vinutha V |
| Address |
#36/1, 12th cross manjunatha layout Basavanapura main road K R puram Bangalore 36 |
| 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 |
| Vinutha V |
Vijayanagar Institute of Medical Sciences |
Room no 44 , Department of OBG, Vijayanagar institute of medical sciences, Ballari
Bellary
KARNATAKA |
8553772905
vinuthav65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIMS ethical 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 |
liquid based cytology |
Cytology studied and compared with pap smear report |
| Intervention |
Pap smear |
Cytology studied and compared with liquid based cytology |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
All women in age group of 21-65 years |
|
| ExclusionCriteria |
| Details |
1) Pregnancy
2) Hysterectomized patients
3) Women who have received medication for cervical intraepithelial cancer treatment
4)Women with active vaginal bleeding
5) Women with frank growth on cervix
6) Women who have never been sexually active
7) Lower genital tract infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Conventional PAP and Liquid Based Cytology results will be compared in terms
of inadequacy of sample, cytological abnormality. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate abnormal smear finding with colposcopic examination over a period of one year |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical cancer is the second most common cancer in women in India. Pap smear is a useful cytological screening method for the prevention of cervical cancer.However conventional pap smear has its own limitation of producing increased unsatisfactory smears. While liquid based cytology has detection rates similar to that of conventional pap smear, produces reduced number of unsatisfactory smears and also has an additional advantage of providing concurrent sample for HPV testing. Hence this study aims at comparing conventional pap smear and liquid based cytology for cervical cancer screening.
|