Clinical trial · Interventional
Acceptability and Efficacy of Self-sampling for Cervical Cancer Screening: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-collected HPV vaginal swab | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- All participants
- description
- Only 1 arm in the study. All women will undergo both self-collected swab and clinician-collected swab
- interventionNames
- Diagnostic Test: Self-collected HPV vaginal swab
Primary outcomes (1)
- measure
- Sensitivity and specificity of self-collected HPV swabs
- timeFrame
- 1 week (time for results of HPV swab to be analysed)
- description
- To determine the sensitivity of self-sampling method compared to physician sampling method for HPV DNA test in cervical cancer screening
Secondary outcomes (1)
- measure
- Participant acceptability of self-collected HPV swabs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion criteria: All women aged between 30-69 years who are attending clinics in NUH. Exclusion criteria: 1. Women who are pregnant 2. Previous total hysterectomy 3. Previous history of cervical cancer 4. Virgin Intacto 5. Negative Pap smear less than 3 years ago.
References
Publications (6)
- RESULTArbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14. PMID 24433684
- RESULTPetignat P, Faltin DL, Bruchim I, Tramer MR, Franco EL, Coutlee F. Are self-collected samples comparable to physician-collected cervical specimens for human papillomavirus DNA testing? A systematic review and meta-analysis. Gynecol Oncol. 2007 May;105(2):530-5. doi: 10.1016/j.ygyno.2007.01.023. Epub 2007 Feb 28. PMID 17335880
- RESULTLatiff LA, Rahman SA, Wee WY, Dashti S, Andi Asri AA, Unit NH, Siah Li SF, Esfehani AJ, Ahmad S. Assessment of the reliability of a novel self-sampling device for performing cervical sampling in Malaysia. Asian Pac J Cancer Prev. 2015;16(2):559-64. doi: 10.7314/apjcp.2015.16.2.559. PMID 25684487
- RESULTKetelaars PJW, Bosgraaf RP, Siebers AG, Massuger LFAG, van der Linden JC, Wauters CAP, Rahamat-Langendoen JC, van den Brule AJC, IntHout J, Melchers WJG, Bekkers RLM. High-risk human papillomavirus detection in self-sampling compared to physician-taken smear in a responder population of the Dutch cervical screening: Results of the VERA study. Prev Med. 2017 Aug;101:96-101. doi: 10.1016/j.ypmed.2017.05.021. Epub 2017 Jun 1. PMID 28579497
- RESULTJin AZ, Louange EC, Chow KY, Fock CW. Evaluation of the National Cervical Cancer Screening Programme in Singapore. Singapore Med J. 2013 Feb;54(2):96-101. doi: 10.11622/smedj.2013032. PMID 23462834
- RESULTDijkstra MG, Heideman DA, van Kemenade FJ, Hogewoning KJ, Hesselink AT, Verkuijten MC, van Baal WM, Boer GM, Snijders PJ, Meijer CJ. Brush-based self-sampling in combination with GP5+/6+-PCR-based hrHPV testing: high concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN. J Clin Virol. 2012 Jun;54(2):147-51. doi: 10.1016/j.jcv.2012.02.022. Epub 2012 Mar 23.