| CTRI Number |
CTRI/2023/03/050680 [Registered on: 14/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To know the number of Human Papilloma Virus Infection among Gynaecologists in Kerala |
|
Scientific Title of Study
|
Human Papilloma Virus -Prevalence & Type Distribution Among Gynaecologists In Kerala State India |
| Trial Acronym |
HPV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preetha George |
| Designation |
Associate Professor |
| Affiliation |
MOSC Medical College, Kolenchery |
| Address |
Department of Obstetrics & Gynaecology
MOSC Medical College Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9447987840 |
| Fax |
|
| Email |
drpreetha69@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetha George |
| Designation |
Associate Professor |
| Affiliation |
MOSC Medical College, Kolenchery |
| Address |
Department of Obstetrics & Gynaecology
MOSC Medical College Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9447987840 |
| Fax |
|
| Email |
drpreetha69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha George |
| Designation |
Associate Professor |
| Affiliation |
MOSC Medical College, Kolenchery |
| Address |
Department of Obstetrics & Gynaecology
MOSC Medical College Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9447987840 |
| Fax |
|
| Email |
drpreetha69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kerala Federation of Obstetrics and Gynecology
TOGS Academia, East Sooryagramam, Thrissur - 680005 |
|
|
Primary Sponsor
|
| Name |
KFOG |
| Address |
KERALA FEDERATION OF OBSTETRICS & GYNAECOLOGY
|
| Type of Sponsor |
Other [Federation of Obstetrics and Gynaecological Societies and clubs of kerala] |
|
|
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 Preetha George |
MOSC Medical College |
Out patient Department Department of Obstetrics and Gynecology
Kolenchery
Kerala-682311
Ernakulam
KERALA |
9447987840
drpreetha69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for carcinoma cervix |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
All married gynecologists in Kerala . |
|
| ExclusionCriteria |
| Details |
Unmarried
Pregnant
Within 45 days after abortion
Menstrual periods
Known case of CA cervix
Persons who had undergone Hysterectomy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detect the number of women with HPV virus on testing |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Genotype of the HPV virus in those women with positive test |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="282"
Sample Size from India="282"
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)
|
20/03/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Cervical cancer is the fourth most common cancer among women globally with
an estimated 5,70,000 new cases in 2018. Nearly 90% of the 3,11000 deaths
worldwide in 2018 occurred in low middle income countries.
The global strategy towards eliminating cervical cancer as a public
health problem adopted by WHO in 2020, recommends a comprehensive
approach to cervical cancer prevention and control. The primary prevention is
by HPV vaccination. Secondary prevention aims at screening women 30 years or
older with a high performance test like HPV test followed by immediate
treatment as quickly as possible. T o end cervical cancer 7/10 women should
be screened by 35 years of age.
|