Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-03-06 @ 4:56 PM
Study NCT ID:
NCT00977392
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2009-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening
Sponsor:
Barts and the London School of Medicine and Dentistry
Organization:
Study Overview
Official Title:
The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: