Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture

Recruiting

• Conditions: Capsular Contracture, Implant; Breast Implant-Associated Anaplastic Large Cell Lymphoma; Breast Implant; Complications

• Registration Number: NCT05017337
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-07-27
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-19
• Primary Completion: 2024-07-27
• Study Completion: 2024-07-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients aged > 16 years
2. Any patient with histopathologically-confirmed ALCL
3. MDT recommendation for capsulectomy
4. Patient consent for capsulectomy

Exclusion Criteria

1. Inability to give informed consent
2. MDT unable to make recommendation for surgery

BASILICA-C

Inclusion criteria:

1. Patients aged > 16 years
2. Any patient with a capsule arising around an implant, or a clinical diagnosis of capsular contracture
3. MDT recommendation for capsulectomy
4. Patient consent for capsulectomy

Exclusion criteria:

1. Inability to give informed consent
2. MDT unable to make recommendation for surgery#
3. More than one previous implant exchange, or previous extensive capsular surgery

BASILICA-N

Inclusion criteria:

1. Patients aged > 16 years
2. Any patient undergoing implant insertion surgery

Exclusion criteria:

1. Inability to give informed consent
2. MDT unable to make recommendation for surgery
3. Previous implant insertion surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Capsular tissue profiling using Multi-OMIC technologies	3 year following final sample collection	Perform multi-OMIC (methylome, transcriptome, proteome) profiling of capsular tissues (CC, BIA-ALCL and control) to determine if differences exist within and between groups (BASILICA A and C).
Immune profiling of peripheral blood mononuclear cells	3 year following final sample collection	Perform immune profiling of peripheral blood mononuclear cells from BIA-ALCL and Non-BIA-ALCL donors (CC and implant naive) to determine if differences exist within and between groups (BASILICA A, C and N)
Immunohistochemical analysis of capsular tissue	3 year following final sample collection	Perform immunohistochemical profiling of capsular tissues (CC, BIA-ALCL and control) and seroma fluid for immune cell subtypes to determine if differences exist within and between groups (BASILICA A and C).

Secondary Outcome Measures

Name	Time	Method
Appraisal of patient clinical characteristics	3 year following final sample collection	Correlate demographic and clinical characteristics of biobank donors with translational scientific dataset (BASILICA A, C and N)

Trial Locations

Locations (2)

Royal Marsden Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

The Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom