Preliminary Registration Detail

Research Registry No : PLRID-00017_V1
 
Postgraduate Research : No
 
University Departmental Research : Yes
 
Name of University : University of Medicine 1
 
Department : Gynaecologic Oncology Department
 
Registration Date : 2020-09-04
 
Principle Investigator : Myint Myint Thinn
 
Co-Investigators : Professor Nwe Mar Tun
 
Title of Research : Accuracy of high risk HPV DNA genotyping, cytology and VIA as the triage strategy for HPV positive women in cervical cancer screening
 
Field of Research : Gynaecological Oncology
 
Preliminary Research Design : Analytic Study
 
Preliminary Research Type : Basic
 
Preliminary Justification : In Myanmar, a national cervical cancer screening program will begin in a short time to reach the WHO target of 70% screening coverage by the year 2013 for 7.6 million eligible women aged 30 to 49 years. According to the national guideline, HPV testing become the primary screening method in public health care facilities. A primary concern of testing for high-risk HPV, is its low positive predictive value, since only a small fraction of women with high-risk HPV will have a persistent infection that is likely to progress to invasive cancer. Therefore, referring all women with high-risk HPV to colposcopy would likely lead to overtreatment and incur high health care costs. In that point, a triage test to confirm the precancerous lesion become compulsory to overcome the unnecessary referral for colposcopy and treatment together with financial burden. This study aims to determine the diagnostic accuracy of HPV genotyping, VIA and cervical cytology as the triage strategies in HPV positive women for detection of premalignant condition of cervix. Those data may help to improve the implementation of upcoming National Screening programme and accomplishment of the national screening guideline.
 
Preliminary Aim : To study the accuracy of high risk HPV DNA genotyping, cytology and VIA as the triage strategy for HPV positive women in cervical cancer screening
 
Preliminary Objectives : 1. To identify the social and demographic characteristics of women tested positive for HPV DNA at the Cervical Cancer Screening Clinic, Yangon Central Women’s Hospital 2. To determine the rate of abnormal triage results with HPV genotyping, cytology and VIA in HPV positive women 3. To compare the diagnostic accuracy of three triage tests for the detection of premalignant lesions in HPV positive women
 
Preliminary Sample Size : 171
 
Preliminary Study Duration : One year
 
Preliminary Study Area : Cervical cancer screening clinic, Central Women's Hospital, Yangon
 
Preliminary Study Method : Women who are eligible in term of the inclusion and exclusion criteria will be recruited and explained about study procedure in details. If they agree, individual written consent (Annex 1) will be obtained and enrolled. History taking and physical examination will be performed. Cervical cytology specimens will be taken with cytobrush from women who are HPV positive for HPV genotyping and cervical cytology (Pap test) followed by visual inspection with acetic acid (VIA). Then, they will have colposcopy and directed cervical biopsy by the candidate for confirmation of the triage tests on the same day. All tissue samples will be sent to pathology department, CWH for histological confirmation. The diagnostic accuracy of HPV genotyping, cervical cytology and VIA will be analyzed and compared by the histological results.
 
Preliminary Research Outcome : The main expected outcomes from this study are prevalence of the HPV positive women in study population, accuracy of the triage tests for the detection of precancerous lesions and their related colposcopy referral rates. This study intends to demonstrate
 
Preliminary Research Finding : The diagnostic accuracy of three triage test in terms of specificity, sensitivity, positive predictive value, negative predictive value as well as accuracy will be analysed.
 
Preliminary Progress Report : Starts to collects cervical samples to test HPV status from the women attending screening clinic. Those with positive results will be recruited to take part in the study.
 
Study Starting Date : 2020-10-01
IRB/PRC/ERC Approval Date : 2020-08-20
 
Placement of IRB/PRC/ERC : Department of Medical Research, Yangon
 
IRB/PRC/ERC Approval Letter/Document : 040920200724262020-104Dr.MyintMyintThinn.pdf
 
Pre-existing Registration ID : No
 
Pre-existing Name of Organization : Yangon Central Women's Hospital
 
Pre-existing Name of Organization Website : -