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CompletedNCT00977392Updated Aug 7, 2013

Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening

An observational study in Health Status Unknown and Precancerous Condition, sponsored by Barts and the London School of Medicine and Dentistry. Completed at 1 site in United Kingdom. Open to female participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by Barts and the London School of Medicine and Dentistry · Observational

Study type
Observational
Enrollment
3,000
Ages
25 Years and older
Sex
Female
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Study summary

RATIONALE: Women who do not undergo routine cervical screening may be more likely to collect a self-sample for human papillomavirus testing.

PURPOSE: This randomized clinical trial is studying self-sampling in women who do not undergo routine cervical screening.

Read the detailed description

OBJECTIVES:

  • To ascertain whether women who do not attend for cervical screening are more likely to respond to the opportunity to collect a self-sample for human papillomavirus (HPV) testing, or to respond to a further invitation to undergo a cervical smear.
  • To ascertain whether such women will attend for further investigation if they have a positive screening test (HPV test or cervical smear).

OUTLINE: Patients are randomized to 1 of 2 arms.

  • Control: Patients receive an invitation for a routine cervical smear and a cervical screening survey. Information regarding attendance for smear or colposcopy is collected at the Primary Care Trust.
  • Study (self-sampling kit): Patients receive an explanatory letter, an information sheet about the study, a consent form, information about human papillomavirus (HPV) and HPV testing, a self-sampling test kit, and an invitation to take their own HPV sample and return it to the research group for processing. Patients also receive a cervical screening survey. Patients who attend for further investigation following a positive HPV result go to St. Mary's Hospital Colposcopy Unit, Paddington. During this visit cervical smear tests are performed and women are offered immediate colposcopy so that they would not need to return for colposcopic examination if their smear test is abnormal.

This study is peer reviewed and funded or endorsed by cancer research UK.

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Conditions studied

  • Health Status Unknown
  • Precancerous Condition

Keywords

  • human papilloma virus infection
  • health status unknown
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In context

Precancerous Conditions

254 studies on the registry are indexed under Precancerous Conditions; 28 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 160 across 64 observational studies indexed under Precancerous Conditions.

Browse Precancerous Conditions studies →

Lead sponsor

Barts and the London School of Medicine and Dentistry is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Women in Westminster Primary Care Trust (PCT) area eligible for routine cervical screening who have not responded to two invitations to attend for smears
  • No women who have written to the PCT to document their refusal to take part in the National Health Service Cervical Screening Program (NHSCSP)
  • No women who are not due for routine screening as part of the NHSCSP

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Have been sexually active

PRIOR CONCURRENT THERAPY:

  • No prior total abdominal hysterectomy
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Study design

Enrollment
3,000 participants (estimated)
Patient registry
No

Interventions

  • Behavioralcompliance monitoring
  • Othercervical Papanicolaou test
  • Othereducational intervention
  • Otherscreening questionnaire administration
  • Othersurvey administration
  • Procedurecolposcopy
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What researchers measure

Primary outcomes

  1. Comparison of the percentages of women responding to the invitation to return a self-sampling kit vs responding to an invitation for a cervical smear

Secondary outcomes

  1. Response to the invitation for further investigation following a positive test result (colposcopy for women with a smear showing mild dyskaryosis or above, smear +/- colposcopy for those with a positive HPV test)

  2. Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening

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Study locations

1 site
  • Barts and the London School of Medicine
    London, England SW15 5PN, United Kingdom
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00977392
Lead sponsor
Barts and the London School of Medicine and Dentistry
First posted
Sep 15, 2009
Start date
Jun 2009
Primary completion
Feb 2010
Completion
Mar 2011
Last update
Aug 7, 2013

Study contacts

Anne Szarewski, MD
principal investigator · Queen Mary University of London
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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