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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977392
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment
Health Status Unknown Precancerous Condition Behavioral: compliance monitoring Other: cervical Papanicolaou test Other: educational intervention Other: screening questionnaire administration Other: survey administration Procedure: colposcopy

Detailed Description:


  • 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.

Study Type : Observational
Estimated Enrollment : 3000 participants
Official Title: The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial
Study Start Date : June 2009
Primary Completion Date : February 2010
Study Completion Date : March 2011

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes


  • 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


  • Not pregnant
  • Have been sexually active


  • No prior total abdominal hysterectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977392

United Kingdom
Barts and the London School of Medicine
London, England, United Kingdom, SW15 5PN
Sponsors and Collaborators
Barts and the London School of Medicine and Dentistry
Principal Investigator: Anne Szarewski, MD Queen Mary University of London

Additional Information: Identifier: NCT00977392     History of Changes
Other Study ID Numbers: CRUK-Westminster-Self-Sampling
CDR0000648274 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN40182307 ( Registry Identifier: ISRCTN (International Standard Randomised Controlled Trial Number Register) )
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: September 2009

Keywords provided by National Cancer Institute (NCI):
human papilloma virus infection
health status unknown

Additional relevant MeSH terms:
Precancerous Conditions