1. Administrative information
AgeX: Nationwide cluster-randomised trials in England of extending the NHS breast screening age range
Statistical analysis plan for the 2025-33 follow-up phase, after randomisation of 4.5 million women in 2009-20 and, in 2020-24, consolidation of long-term data linkage and finalisation of the 3.0 million to be included in the main analyses population.
ISRCTN registration: ISRCTN3392440
ClinicalTrials.gov identifier: NCT01081288
1.1 History of revisions
|
Protocol version |
SAP version |
Description and reason for change |
Date |
|
6.0 |
1.0 |
First draft |
12.2023 |
|
7.0 |
1.1 |
Revised following comments from the trial management group (TMG) |
11.2024 |
|
7.1 |
1.2 |
Years since randomisation to diagnosis of fatal breast cancer categorised <4 and ≥4/unknown instead of <4 and ≥4 |
5.2025 |
1.2 Roles and responsibilities
The SAP was developed and revised collaboratively by all the co-principal investigators.