Routine MammographyNCT00890864
Pilot Study: Age Extension of NHS Breast Screening Programme
A study testing Invitation for breast screening in people with Routine Mammography, run by University of Oxford.
Trial summary
The purpose of this pilot study is to assess the feasibility and acceptability of randomising the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer sites in different areas of England. Read more about this study
- Who is it for?
- Ages 47 to 73 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Routine Mammography
- What is being tested?
- Invitation for breast screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36,000 participants
- Where
- No sites listed yet
- Study dates
- May 2009to May 2010
- Phase
- Interventional
- 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 47 to 73 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female, and living in one of the 6 pilot areas, and
- aged 47-49 or 71-73 years, and
- in a screening invitation batch that includes their age group.
Who cannot join
None listed.
About this study
Official title: Pilot Study of the Feasibility and Acceptability of Randomising the phasing-in of the Age Extension of the NHS Breast Screening Programme in England
The purpose of this pilot study is to assess the feasibility and acceptability of randomising the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer sites in different areas of England.
Read the detailed description
Currently all women are invited for breast screening between the ages of 50 and 70. In 2007 the Cancer Reform Strategy announced that from 2012 the NHS Breast Screening Programme would be extended to cover women between the ages of 47 and 73. This means that all women will get two extra screening invitations in their lifetime. It also means that all women will get their first invitation before age 50. As capacity does not allow for full immediate roll out across the whole of England, the age extension will be phased-in with full coverage from 2012. Randomising this phasing-in would provide unbiased evidence on the extent to which it is beneficial to extend the age range for breast screening and whether an extra screen at younger or older ages is more worthwhile. To date there is no clear evidence on this as no trial has looked at the added value of one extra screen within an existing screening programme. This pilot study will assess the feasibility and acceptability of randomising the phasing-in of the age extension in six volunteer sites in different areas of England.
- Conditions
- Routine Mammography
- Being tested
- Invitation for breast screening
- Keywords
- Breast screening, Mammogram, Routine screening programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation for breast screeningOther
Also called Invitation for mammogram
Invitation for breast screening to women in different age groups
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Women aged 47-49 invited for breast screening Receives: Other: Invitation for breast screening |
| 2 | Active comparator | Women aged 71-73 invited for breast screening Receives: Other: Invitation for breast screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening uptake among women invited for screening in the extended age groups
Measured: One year
Secondary outcomes (2)
Workload associated with inviting these new age groups for screening
Measured: One year
Self-referrals among women in the pilot areas aged 47-49 or 71-73 but who were not invited for screening
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Routine MammographyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Cancer Screening Programmes, Department of Health, United Kingdom
- Investigators
- Julietta Patnick, BA (Hons), Principal investigator, NHS Cancer Screening Programmes; also, Oxford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890864
- Sponsor's protocol ID
- 09/H0710/2
- Other IDs
- ISRCTN50037017
- Status last verified
- Jul 2010
- First submitted
- 26 Jan 2009
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Moser K, Sellars S, Wheaton M, Cooke J, Duncan A, Maxwell A, Michell M, Wilson M, Beral V, Peto R, Richards M, Patnick J. Extending the age range for breast screening in England: pilot study to assess the feasibility and acceptability of randomization. J Med Screen. 2011;18(2):96-102. doi: 10.1258/jms.2011.011065.
PubMed 21852703
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Feasibility and Acceptability of Randomising the phasing-in of the Age Extension of the NHS Breast Screening Programme in England
- ClinicalTrials.gov ID
- NCT00890864
- Acronym / sponsor ID
- 09/H0710/2
- Conditions
- Routine Mammography
- Keywords
- Breast screening, Mammogram, Routine screening programme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- NHS Cancer Screening Programmes, Department of Health, United Kingdom
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Apr 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.
The purpose of this pilot study is to assess the feasibility and acceptability of randomising the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer sites in different areas of England.
Detailed description
Currently all women are invited for breast screening between the ages of 50 and 70. In 2007 the Cancer Reform Strategy announced that from 2012 the NHS Breast Screening Programme would be extended to cover women between the ages of 47 and 73. This means that all women will get two extra screening invitations in their lifetime. It also means that all women will get their first invitation before age 50. As capacity does not allow for full immediate roll out across the whole of England, the age extension will be phased-in with full coverage from 2012. Randomising this phasing-in would provide unbiased evidence on the extent to which it is beneficial to extend the age range for breast screening and whether an extra screen at younger or older ages is more worthwhile. To date there is no clear evidence on this as no trial has looked at the added value of one extra screen within an existing screening programme. This pilot study will assess the feasibility and acceptability of randomising the phasing-in of the age extension in six volunteer sites in different areas of England.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Invitation for breast screeningWomen aged 47-49 invited for breast screening |
| 2 | Active comparator | Other: Invitation for breast screeningWomen aged 71-73 invited for breast screening |
Who may qualify
- Ages
- 47 to 73 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female, and living in one of the 6 pilot areas, and
- aged 47-49 or 71-73 years, and
- in a screening invitation batch that includes their age group.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Invitation for breast screeningAlso: Invitation for mammogramInvitation for breast screening to women in different age groups | Other | 1, 2 |
Primary outcome
Screening uptake among women invited for screening in the extended age groups
Time frame: One year
2 secondary outcomes
Workload associated with inviting these new age groups for screening
Time frame: One year
Self-referrals among women in the pilot areas aged 47-49 or 71-73 but who were not invited for screening
Time frame: One year
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 19 Jul 2010.
- Derived from this study: PubMed 21852703Moser K, Sellars S, Wheaton M, Cooke J, Duncan A, Maxwell A, Michell M, Wilson M, Beral V, Peto R, Richards M, Patnick J. Extending the age range for breast screening in England: pilot study to assess the feasibility and acceptability of randomization. J Med Screen. 2011;18(2):96-102. doi: 10.1258/jms.2011.011065.
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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.
Julietta Patnick, BA (Hons) principal investigator
NHS Cancer Screening Programmes; also, Oxford University
Questions about this trial
What is this clinical trial studying?
A study testing Invitation for breast screening in people with Routine Mammography, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. 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 19 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Screening uptake among women invited for screening in the extended age groups (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00890864, which also lists 1 linked publication.
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 19 Jul 2010; AzTrials last refreshed its copy on 30 Oct 2026.