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

August 6, 2013 updated by: Barts and the London School of Medicine and Dentistry

The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SW15 5PN
        • Barts and the London School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts and the London School of Medicine and Dentistry

Investigators

  • Principal Investigator: Anne Szarewski, MD, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 12, 2009

First Submitted That Met QC Criteria

September 12, 2009

First Posted (Estimate)

September 15, 2009

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Precancerous Condition

Clinical Trials on survey administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe