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

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ClinicalTrials.gov Identifier: NCT00977392
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date September 12, 2009
First Posted Date September 15, 2009
Last Update Posted Date August 7, 2013
Study Start Date June 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2009)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00977392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 12, 2009)
  • 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)
  • Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening
Official Title The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial
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.

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.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Health Status Unknown
  • Precancerous Condition
Intervention
  • Behavioral: compliance monitoring
  • Other: cervical Papanicolaou test
  • Other: educational intervention
  • Other: screening questionnaire administration
  • Other: survey administration
  • Procedure: colposcopy
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: September 12, 2009)
3000
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2011
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00977392
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) )
EU-20963
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Barts and the London School of Medicine and Dentistry
Collaborators Not Provided
Investigators
Principal Investigator: Anne Szarewski, MD Queen Mary University of London
PRS Account National Cancer Institute (NCI)
Verification Date September 2009