Role of following up patients with breast cancer with a mammogram in detecting recurrence
| ISRCTN | ISRCTN37620362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37620362 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of East Anglia |
| Funder | Investigator initiated and funded |
- Submission date
- 15/02/2021
- Registration date
- 20/02/2021
- Last edited
- 30/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer is the most common cancer in women. Routinely women who are diagnosed with breast cancer will be followed with a yearly mammogram (an X-ray test) for a minimum of 5 years. There is a little evidence that routine mammogram follow-up of patients treated for early breast cancer helps to detect recurrences or new cancers. The aim of this study is to follow up patients with early breast cancer for recurrences and new primary cancers in order to determine the role of mammogram follow up.
Who can participate?
Patients who were diagnosed with breast cancer either by screening or presented with symptoms from 2001 to 2006.
What does the study involve?
This is an observational study that follows up patients who had breast cancer from 2001 to 2006 for a minimum of 10 years or until recurrence of cancer to find out whether this recurrence was detected by follow-up mammogram.
What are the possible benefits and risks of participating?
There are no expected benefits or risks for participants
Where is the study run from?
Addenbrooke’s Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2015 to January 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Wafa Taher
Wafa.taher@nhs.net
Contact information
Scientific
41 Goodwood Court
54 57 Devonshire Street
London
W1W 5EF
United Kingdom
| Phone | +44 (0)7808666349 |
|---|---|
| wafa.taher@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre retrospective primary observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | The effectiveness of mammography surveillance after treatment of primary breast cancer: a single-centre retrospective cohort study |
| Study acronym | MaSATPriBrCa |
| Study objectives | Is mammography surveillance after treatment of primary breast cancer efficient at detecting recurrence and new primaries? |
| Ethics approval(s) | Access to patients’ data was obtained through an official data request to Addenbrooke’s Hospital Research Department. Formal ethics committee clearance was not needed as this was a service evaluation. |
| Health condition(s) or problem(s) studied | New breast cancer/recurrence in patients with primary breast cancer after treatment |
| Intervention | Patients who had primary breast cancer during the years 2001 to 2006 were included and followed up for a minimum of 10 years. Patients who developed recurrence/new primaries are studied to find if that incident was picked up by a mammogram. All data are collected from the hospital database. |
| Intervention type | Other |
| Primary outcome measure(s) |
Effectiveness of follow-up mammography at detecting recurrences/new cancers, measured using the hospital database with a minimum of 10 years of follow-up |
| Key secondary outcome measure(s) |
The rate of detection of recurrence/new primaries by mammogram between patients whose original tumour was detected by screening and those who presented symptomatically, measured using the hospital database with a minimum of 10 years of follow-up |
| Completion date | 01/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 2552 |
| Total final enrolment | 2530 |
| Key inclusion criteria | Patients who had primary breast cancer during year 2001 to 2006 |
| Key exclusion criteria | 1. Patients with distant metastasis or regional recurrence (chest wall, mastectomy scar or axilla) 2. Patients who were lost to follow-up or had no records 3. Patients who died because of reasons other than breast cancer during 10 years of follow-up and who were recurrence-free at the time of death |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Wafa Taher (wafa.taher@nhs.net). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/04/2021 | 30/03/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/03/2023: Publication reference added.
18/02/2021: Trial's existence confirmed by Cambridge Breast Cancer Research Unit.
