Health Status UnknownNCT00977392
Self-Sampling in Women Who Do Not Undergo Routine Cervical Screening
An observational study of Health Status Unknown and Precancerous Condition, run by Barts and the London School of Medicine and Dentistry at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Status Unknown, Precancerous Condition
- What is being tested?
- compliance monitoring, cervical Papanicolaou test and educational intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 3,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barts and the London School of Medicine
London, England, SW15 5PN
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Status Unknown, Precancerous Condition
- Being tested
- compliance monitoring, cervical Papanicolaou test, educational intervention, screening questionnaire administration, survey administration
- Keywords
- human papilloma virus infection, health status unknown
- Medical subject headings
- Precancerous Conditions, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compliance monitoringBehavioural
cervical Papanicolaou testOther
educational interventionOther
screening questionnaire administrationOther
survey administrationOther
colposcopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Status UnknownStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts and the London School of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Investigators
- Anne Szarewski, MD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977392
- Sponsor's protocol ID
- CRUK-Westminster-Self-Sampling
- Other IDs
- CDR0000648274, ISRCTN40182307, EU-20963
- Status last verified
- Sep 2009
- First submitted
- 12 Sep 2009
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of Self-sampling in Women Who do Not Attend for Cervical Screening - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00977392
- Acronym / sponsor ID
- CRUK-Westminster-Self-Sampling
- Conditions
- Health Status Unknown, Precancerous Condition
- Keywords
- human papilloma virus infection, health status unknown
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Barts and the London School of Medicine and DentistryUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compliance monitoring | Behavioural | – |
| cervical Papanicolaou test | Other | – |
| educational intervention | Other | – |
| screening questionnaire administration | Other | – |
| survey administration | Other | – |
| colposcopy | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- 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.Link provided by the sponsor.
Related trials for Health Status Unknown
Active, not recruiting
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
Conditions Influencing Health Status, Healthy
Active, not recruiting
Patients Navigators in Facilitating Weight Management in Obese Participants
Health Status Unknown, Obesity
Active, not recruiting
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
Body Mass Index 25 or Greater, BRCA1 Gene Mutation
Active, not recruiting
Your Health Matters! (Tu Salud ¡Si Cuenta!): Promoting Healthy Lifestyles in Latino Families
Family Member, Health Status Unknown
Active, not recruiting
Diagnosing Clinically Significant Prostate Cancer In African American and White Men With Elevated PSA
Health Status Unknown, Elevated PSA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Szarewski, MD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Status Unknown and Precancerous Condition, run by Barts and the London School of Medicine and Dentistry at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.