Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05017337 |
| Other study ID # |
CCR5363 |
| Secondary ID |
249930 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 27, 2021 |
| Est. completion date |
July 27, 2024 |
Study information
| Verified date |
January 2023 |
| Source |
Royal Marsden NHS Foundation Trust |
| Contact |
Joseph Ward, MBChB MRCS |
| Phone |
02073528171 |
| Email |
joseph.ward[@]icr.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
BASILICA is a UK NIHR Biomedical Research Centre funded study recruiting patients at The
Royal Marsden NHS Foundation Trust. The study aims to obtain blood and tissue samples from
patients with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), capsular
contracture and implant-naïve patients undergoing primary implant insertion surgery for
translational scientific analysis.
Description:
BASILICA is a translational research study being undertaken at The Royal Marsden NHS
Foundation Trust that aims to investigate aetiology of breast implant-associated anaplastic
large cell lymphoma (BIA-ALCL), capsular contracture (CC) as well as the immune changes that
occur in implant-naïve patients undergoing primary implant insertion surgery.
BIA-ALCL is a rare tumour seen in a very small number of women with textured breast implants.
Overall incidence is estimated at 2 per 1,000,000 women/year with a lifetime risk of 1 in
30,000 for textured breast implants. It presents commonly with a sudden seroma around an
implant or, occasionally, as a soft tissue mass adjacent to the implant capsule. In 2016, the
disease was classified by the WHO as a CD30+ ALK- non-Hodgkin's T-cell lymphoma. Surgery (en
bloc capsulectomy) is curative for the majority of cases. Scientific appreciation of
aetiology is limited but current thinking implicates chronic inflammation as a protagonist
for pathogenesis through hypertonic antigen presentation.
CC is the fibrotic tightening of a capsule that forms around a breast implant and leads to
palpable hardening, pain and visible distortion. The biggest risk factor is radiotherapy with
quoted incidence rates as high as 50% in some series. Management is a significant clinical
challenge with limited options and high recurrence rates. The most common surgical approaches
are to remove the capsule (capsulectomy) or exchange and change the anatomical plane of
implant placement. The only definitive surgical management is to explant the implant and
perform autologous breast reconstruction, if feasible, or, no reconstruction at all.
BASILICA will obtain pathological capsular tissue (CC and BIA-ALCL) and non-pathological
capsule tissue (control tissue) as well as blood samples from patients undergoing any form of
implant-related surgery. The investigators aim to use these tissues to perform translational
analyses investigating the aetiology of each pathology and the physiological immunological
response to silicone implant insertion. They hypothesise that 1) specific differences exist
in the immunological and matrisomal profiles of CC and BIA-ALCL that drive the pathogenesis
of each clinical entity, and that 2) insertion of a silicone prosthesis causes changes in the
composition of the humoral and cellular components of the circulating immune system.
