| CTRI Number |
CTRI/2024/04/065698 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of methods of cervical cancer screening |
|
Scientific Title of Study
|
Comparison of Primary Human Papilloma Virus testing, Liquid based cytology and Co-testing for cervical cancer screening |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Arora |
| Designation |
PG Resident Obstetrics and Gynecology |
| Affiliation |
ABVIMS, Dr. RML hospital , Delhi |
| Address |
ABVIMS and Dr. RML hospital , Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi
Central
DELHI
110001
India |
| Phone |
8130929389 |
| Fax |
|
| Email |
dr.sneha0608@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamna Datta |
| Designation |
Professor Obstetrics and Gynecology |
| Affiliation |
ABVIMS and Dr. RML hospital , Delhi |
| Address |
ABVIMS and Dr. RML hospital , Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi
Central
DELHI
110001
India |
| Phone |
9891145329 |
| Fax |
|
| Email |
kamnadatta29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamna Datta |
| Designation |
Professor Obstetrics and Gynecology |
| Affiliation |
ABVIMS and Dr. RML hospital , Delhi |
| Address |
ABVIMS and Dr. RML hospital , Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi
Central
DELHI
110001
India |
| Phone |
9891145329 |
| Fax |
|
| Email |
kamnadatta29@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML hospital,Baba Kharak Singh Marg,
Near Gurudwara Bangla Sahib,
Connaught Place, New Delhi, Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Sneha Arora |
| Address |
ABVIMS and Dr. RML hospital , Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kamna Dutta |
ABVIMS and Dr. RML hospital , Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sneha Arora |
ABVIMS and Dr. RML hospital |
Room 14/16/17, Gyne-OPD, Department of Obstetrics and Gynaecology
Central
DELHI |
8130929389
dr.sneha0608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS, Dr. RML Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre-malignant and malignant lesions of 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 |
Women more than 30 years of age |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Women with history of cervical surgery
3. Women diagnosed with cervical cancer
4. HPV vaccinated women
5. Post hysterectomised women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detection of pre-malignant and malignant lesions of cervix |
More than 30 years of age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of HPV infection in Indian women |
More than 30 years of age |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
22/04/2024 |
| 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
|
A prospective study will be performed on married women, above the age of 30 years presenting to OPD of Department of obstetrics and gynaecology ABVIMS and Dr RML NEW DELHI hospital. Those who are found to meet the inclusion and exclusion criteria will be explained the study details in their own language and a written informed consent to participate in the study will be taken. History and thorough examination shall be as per attached proforma. A per speculum examination using Cusco’s bivalve metallic speculum will be performed and samples for both HPV DNA and LBC will be collected using HPV kit and cytology brush respectively and will be sent for examination. Those who come out to be screen positive will be subjected to cervical biopsy and managed as per hospital protocols. |