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

NCT03813576 | Unknown

• 1 other identifier: 2018/00846
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Cervical Cancer; Cervical Dysplasia; Human Papillomavirus Infection

Keywords

screening; cervical cancer; primary prevention; human papillomavirus infection; acceptability; feasibility

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of self-collected HPV swabs

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

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

Secondary Outcomes (1)

• Participant acceptability of self-collected HPV swabs

  15 minutes (time for questionnaire to be filled in by participant)

Study Arms (1)

All participants

OTHER

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

Diagnostic Test: Self-collected HPV vaginal swab

Interventions

Self-collected HPV vaginal swab DIAGNOSTIC_TEST

Patients will be instructed on how to collect a vaginal swab on themselves which will then be processed for presence of HPV DNA.

All participants

Eligibility Criteria

• Age: 30 Years - 69 Years
• Gender Eligibility Details: All participants are female to be applicable for cervical cancer screening
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Related Publications (6)

• Arbyn 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 RESULT

• Petignat 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 RESULT

• Latiff 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 RESULT

• Ketelaars 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 RESULT

• Jin 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 RESULT

• Dijkstra 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.

  PMID: 22445557 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ismail Pratt Ida, MBBS

  National University Hospital, Singapore

  STUDY CHAIR

Central Study Contacts

Li Min Lim, MBBS

CONTACT

96564934; li_min_lim@nuhs.edu.sg

Grace Ming Fen Grace, MBBS

CONTACT

96340882; grace_chan@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All women will undergo a clinical-collected cervical HPV swab and a self-collected vaginal HPV swab and the results of both swabs compared. The women will be randomised to the sequence of which they undergo the clinical-collected swab first or the self-collected swab first.

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 23, 2019
• Study Start: March 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share