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

Precancerous Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977392
• Other study ID #: CRUK-Westminster-Self-Sampling
• Secondary ID: CDR0000648274ISR
• Status: Completed
• Phase: N/A
• First received: September 12, 2009
• Last updated: August 6, 2013
• Start date: June 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: March 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Health Status Unknown
• Precancerous Condition
• Precancerous Conditions

Intervention

Behavioral:
• compliance monitoring

Other:
• cervical Papanicolaou test

• educational intervention

• screening questionnaire administration

• survey administration

Procedure:
• colposcopy

Locations

Country	Name	City	State
United Kingdom	Barts and the London School of Medicine	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Barts and the London School of Medicine and Dentistry

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	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)			No
Secondary	Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening			No

External Links

•   HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial. Br J Cancer. 2011 Mar 15;104(6):915-20. doi: 10.1038/bjc.2011.48. Epub 2011 Feb 22.