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临床试验/NCT03813576
NCT03813576Unknown不适用

Acceptability and Efficacy of Self-sampling for Cervical Cancer Screening: A Pilot Study

National University Hospital, Singapore0 个研究点目标入组 300 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
主要终点
Sensitivity and specificity of self-collected HPV swabs

研究概览

简要总结

In Singapore, the current cervical cancer screening uptake among women in Singapore has remained at low 50% since its introduction in 2004. It has been widely reported that under-screened women have the highest risk of cervical cancer. Self-sampling HPV DNA screening may be a solution to the low uptake rates of local women, particularly among the under-screened population in Singapore. Self-sampling comprises women using a swab to obtain samples from their vagina.

In this study, we are comparing the sensitivity of detecting HPV positive women using HPV DNA test with self-sampling using flocked swab with the current physician sampling method. We also aim to determine acceptability of self-sampling HPV DNA test using flocked swab in cervical cancer screening. Designed as a feasibility study, it will comprise a prospective study of 300 women attending clinics in National University Hospital (NUH) and National Cancer Institute Singapore (NCIS).

详细描述

Cervical cancer is one of the leading causes of death worldwide. The recognition that cervical cancer is caused by persistent oncogenic HPV virus has caused a considerable paradigm shift in screening and prevention of cervical cancer by the introduction of HPV DNA test and the HPV vaccine. HPV DNA test as an alternative to the current and more traditional cytology only screening has been shown to have higher sensitivity in detecting high grade cervical intraepithelial neoplasia (CIN) to allow for earlier treatment of pre-cancer thus preventing development of cervical cancer in future. Singapore as the rest of the world are in the transition toward the paradigm shift of using HPV DNA test as part of the cervical cancer screening strategy compared to the traditional cytology only screening. However, any cancer screening program to make an impact, an uptake of 70% of more is desired and currently this strategy resulting to the reduction in cervical cancer incidence are only seen in countries adopting an organized cervical cancer screening strategy such as the United Kingdom. Currently, HPV DNA testing has widely been shown to be higher sensitivity to pick up pre-cancer and allow for earlier treatment of pre-cancer. Uptake for cervical cancer screening has remains suboptimal since introduction of the national cervical cancer screening using cytology only method in 2004.

A study published by Jin et.al. in Singapore Medical Journal in 2013 evaluating the progress of cervical cancer screening Singapore (CSS) since its introduction showed that CSS did not make its aim to get 80% uptake for cervical cancer screening for eligible women using cytology only method

Self-sampling in cervical cancer screening

Cervical cancer screening with HPV DNA test is more sensitive than cytology only method to detect pre-cancer cervical cells. It is now well established that cervical cancer screening with HPV DNA test is a much more sensitive method to detect pre-cancer cervical cells compared to cytology only method.

The traditional way of taking a cervical cancer screening involves a physician inserting a speculum into the vagina to visualize the cervix and brushing the surface of the cervix using a cytology brush or spatula. This will collect exfoliated cervical cells to be sent for cytology review to detect any abnormal or pre-cancerous looking cells. Currently HPV DNA test is performed using the same method as taking a pap smear. However, various studies have shown that for HPV DNA test, self-sampling method is a good alternative to physician sampling (Appendix C). Current self-sampling methods in the market are expensive and not cost effective especially if targeting under screeners. There are however, various self-sampling HPV DNA test device in the market. These devices such as the Delphi Screener are expensive and would not be a cost-effective alternative method for women especially in the under screeners in Singapore. Studies have shown that those who do not come for regular cervical cancer screening are usually associated with a lower socioeconomic background. To encourage the under screeners to take up screening, the method should not only be accessible to them but also affordable. The Copan Floq swab has already been used in NUH for Chlamydia testing and it is highly affordable at 3 SGD per swab. Our study would like to determine that using this affordable swab for self-sampling is as sensitive in detecting high risk HPV as a physician sampling method.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
30 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •All women aged between 30-69 years who are attending clinics in NUH.

排除标准

  • •Women who are pregnant
  • •Previous total hysterectomy
  • •Previous history of cervical cancer
  • •Virgin Intacto
  • •Negative Pap smear less than 3 years ago.

研究组 & 干预措施

All participants

Other

Only 1 arm in the study. All women will undergo both self-collected swab and clinician-collected swab

干预措施: Self-collected HPV vaginal swab (Diagnostic Test)

结局指标

主要结局

Sensitivity and specificity of self-collected HPV swabs

时间窗: 1 week (time for results of HPV swab to be analysed)

To determine the sensitivity of self-sampling method compared to physician sampling method for HPV DNA test in cervical cancer screening

次要结局

  • Participant acceptability of self-collected HPV swabs(15 minutes (time for questionnaire to be filled in by participant))

研究者

申办方类型
Other
责任方
Sponsor

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