| CTRI Number |
CTRI/2023/01/049322 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
09/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HPV test of urine and self-collected vaginal samples for cervical cancer screening |
|
Scientific Title of Study
|
Concordance between urine and self-collected vaginal samples for high risk hpv detection in 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 |
SREEYA BOSE |
| Designation |
MEDICAL CONSULTANT |
| Affiliation |
CHITTARANJAN NATIONAL CANCER INSTITUTE |
| Address |
DEPARTMENT OF GYNECOLOGY ONCOLOGY
ROOM NUMBER 404-A
37, S.P MUKHERJEE ROAD
Kolkata
WEST BENGAL
700026
India |
| Phone |
9765421750 |
| Fax |
|
| Email |
sreeyabose@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RANAJIT MANDAL |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
CHITTARANJAN NATIONAL CANCER INSTITUTE |
| Address |
DEPARTMENT OF GYNECOLOGY ONCOLOGY
ROOM NUMBER 404-A
37, S.P MUKHERJEE ROAD
Kolkata
WEST BENGAL
700026
India |
| Phone |
9831002078 |
| Fax |
|
| Email |
kranajitmandal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SREEYA BOSE |
| Designation |
MEDICAL CONSULTANT |
| Affiliation |
CHITTARANJAN NATIONAL CANCER INSTITUTE |
| Address |
DEPARTMENT OF GYNECOLOGY ONCOLOGY
ROOM NUMBER 404-A
37, S.P MUKHERJEE ROAD
Kolkata
WEST BENGAL
700026
India |
| Phone |
9765421750 |
| Fax |
|
| Email |
sreeyabose@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Monetary support is from the Institutes internal fund from the Ministry of Health and Family Welfare. |
|
|
Primary Sponsor
|
| Name |
CHITTARANJAN NATIONAL CANCER INSTITUTE |
| Address |
DEPARTMENT OF GYNECOLOGY ONCOLOGY
ROOM NO 404-A
37, S.P MUKHERJEE ROAD
KOLKATA-700026 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SREEYA BOSE |
Chittaranjan National Cancer Institute |
Room Number 404-A
37 S P Mukherjee Road.
Kolkata-700026
Kolkata
WEST BENGAL |
9765421750
sreeyabose@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHITTARANJAN NATIONAL CANCER INSTITUTE INSTITUITIONAL ETHICS COMMITTEE |
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 |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women between 30-60 years willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1) Women with previous hysterectomy
2) Previously diagnosed as cervical cancer or precancer lesions.
3) Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse concordance between first void urine and self collected vaginal sample |
2yr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the acceptability of urine testing for cervical cancer screening.
To collect data on the costs associated with implementation of HPV screening by self-sampling and urine analysis with a payer perspective to compare them.
|
2yr |
|
|
Target Sample Size
|
Total Sample Size="2453"
Sample Size from India="2453"
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)
|
06/02/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Screening activities will involve women in the age group 30 – 60 years through community based screening camps. 2. The procedure will involve self-collection of vaginal samples and first void urine sample. 3. The samples will be tested using Cobas 4800 at hospital laboratory. 4. A questionnaire will be filled up regarding socio-demographic information and acceptability of screening methods. 5. There will be further screening of positive patients by colposcopy followed by treatment which will be either thermal ablation or large loop excision of the transformation zone. 6. Data will be collected on the costs associated with implementation of HPV screening by self sampling and urine analysis with a payer perspective to compare them. 7. Supervision and review of data at regular intervals. 8. Compilation, data analysis and publication. |