Comparison of Primary Human Papilloma Virus testing, Liquid based cytology and Co-testing for cervical cancer screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Detection of pre-malignant and malignant lesions of cervix
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women more than 30 years of age.
Exclusion Criteria
- •Pregnant women
- •Women with history of cervical surgery
- •Women diagnosed with cervical cancer
- •HPV vaccinated women
- •Post hysterectomised women.
Outcomes
Primary Outcomes
Detection of pre-malignant and malignant lesions of cervix
Time Frame: More than 30 years of age
Secondary Outcomes
- Prevalence of HPV infection in Indian women(More than 30 years of age)
Investigators
Sneha Arora
ABVIMS, Dr. RML hospital , Delhi