Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Barts and the London School of Medicine and Dentistry
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00977392
First received: September 12, 2009
Last updated: January 27, 2010
Last verified: September 2009
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Purpose
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 | Intervention |
|---|---|
|
Health Status Unknown Precancerous Condition |
Behavioral: compliance monitoring Other: cervical Papanicolaou test Other: educational intervention Other: screening questionnaire administration Other: survey administration Procedure: colposcopy |
| Study Type: | Observational |
| Official Title: | The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial |
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 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 [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) [ Designated as safety issue: No ]
- Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening [ Designated as safety issue: No ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977392
Locations
| United Kingdom | |
| Barts and the London School of Medicine | Recruiting |
| London, England, United Kingdom, SW15 5PN | |
| Contact: Anne Szarewski, MD 44-7831-840-529 | |
Sponsors and Collaborators
Barts and the London School of Medicine and Dentistry
Investigators
| Principal Investigator: | Anne Szarewski, MD | Queen Mary University of London |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00977392 History of Changes |
| Other Study ID Numbers: | CDR0000648274, CRUK-Westminster-Self-Sampling, ISRCTN-40182307, EU-20963 |
| Study First Received: | September 12, 2009 |
| Last Updated: | January 27, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
human papilloma virus infection health status unknown |
Additional relevant MeSH terms:
|
Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013