Clinical trial NCT05017337: Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture
Official title: A Translational Study of Breast-implant assocIated anaplastIc Large Cell Lymphoma and Capsular Contracture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Implant-Associated Anaplastic Large Cell Lymphoma
Capsular Contracture, Implant
Breast Implant; Complications
Keywords: BIA-ALCL
Capsular Contracture
Silicone Breast Implants
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a histopathological diagnosis of BIA-ALCL (BASILICA-A), clinical diagnosis of capsular contracture (BASILICA-C) or implant naive patients undergoing implant insertion surgery (BASILICA-N)

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.

Eligibility criteria: BASILICA-A

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

Primary outcomes:
measure: Immunohistochemical analysis of capsular tissue
timeFrame: 3 year following final sample collection
measure: Capsular tissue profiling using Multi-OMIC technologies
timeFrame: 3 year following final sample collection
measure: Immune profiling of peripheral blood mononuclear cells
timeFrame: 3 year following final sample collection
Secondary outcomes:
measure: Appraisal of patient clinical characteristics
timeFrame: 3 year following final sample collection
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Aadil Khan, FRCS (Plast)
role: PRINCIPAL_INVESTIGATOR
References: