[Criteria] [Data capture] [Data items] [Work-plan]
Basic work-plan for participating centres
Starting up:
- LREC approval is not required. The terms of the MREC approval granted stated that LREC only need to be informed about a centres participation in the study. The new standard operating procedures that came into force as of 01/03/2004, state there is no need to inform the LREC or apply for SSA.
- Inform the Trust R&D group you are participating in the study.
- Send a copy of the R&D approval letters to the Study Co-ordinator.
- Liaise with study co-ordinator and local cancer research network to establish procedures and responsibilities for data retrieval and transfer.
Recruitment:
- Potential participants should have a risk assessment, including three-generation family history, performed by an appropriately experienced member of staff. Subjects already under management at the centre are eligible, even if they have already been screened (their first study screen should be the one immediately following recruitment, however).
- First check that inclusion criteria are satisfied (pages 1) and that the potential recruit has none of the exclusion criteria.
- If eligible, and subject gives consent, recruit. Copies of consent forms to be sent to study co-ordinator at end of each month.
- Record baseline data for tables 1 and 1a (page 3 & 4).
- Regularly transfer baseline data to study co-ordinator.
Screening:
- Invite each subject to annual mammography for five years (six screens in all). Slippage to more than 18 months between scheduled screens should not occur (if a recruit fails to attend a screen, invite her again one year later as per protocol).
- Record the data in table 2 (page 4) for each screening episode. Some of the data (for example the updated menopausal factors) may not be known but the basic screening details and outcomes must be recorded.
- Regularly transfer screening data to study co-ordinator.
Cancers:
- Every effort must be made to identify all breast cancers occurring in women recruited, whether detected at screening or not. Regular checks should be made with local pathology laboratories and treatment centres for breast cancers in recruits but diagnosed outside the screening programme (e.g. interval cancer and non-attenders).
- For each centre record data in table 3 (page 5). Some data may not be available, but as a minimum, relevant dates and basic pathology data (invasive status, size, node status, grade) should be recorded.
- In view of the likely small numbers of cancers per centre, it may be more convenient to transfer cancer data to the study co-ordinator as each single case arises.
Any queries or further information can be obtained from the study co-ordinator.