BASILICA
Research type
Research Study
Full title
A translational study of breast-implant associated anaplastic large cell lymphoma and capsular contracture (BASILICA)
IRAS ID
249930
Contact name
Aadil Khan
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) and capsular contracture (CC) are two discrete pathological entities that arise in response to silicone breast implants. Whilst BIA-ALCL is a rare disease with around 450 cases reported internationally, symptomatic CC is much more common occurring in 38% of women undergoing breast reconstruction (and around half of women undergoing radiotherapy). Immunological, microbiological and fibrotic late-adverse effects following radiotherapy have all been implicated in their aetiology but there is a paucity of information regarding the relative contributions and underlying mechanisms.
BASILICA will recruit patients into a 3-arm translational biobanking study that will collate blood and tissue samples from patients with breast implant associated lymphomas (BASILICA A), CC (BASILICA C) and implant naive (BASILICA N) patients undergoing surgery at the Royal Marsden Hospital. Eligible patients older than 18 years and consenting to surgery on MDT advice will be identified through breast and haemato-oncology MDTs. Pre-operative diagnostic biopsies (BASILICA A only and only when standard of care), intra-operative capsular tissue samples, control skin and fat samples, as well as pre- and post-operative blood samples will be taken to investigate the drivers of each condition's pathogenesis. In particular, samples will be used to characterise the immune profile of breast implant associated lymphomas, CC and their respective mediators as well as changes in extracellular matrix through multi-OMIC profiling. Patients will cease study participation at 12 months post-op for the BASILICA A and N groups and at 4 weeks post-op for the BASILICA C group.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0061
Date of REC Opinion
20 Apr 2021
REC opinion
Further Information Favourable Opinion