Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture (BASILICA)

January 17, 2023 updated by: Royal Marsden NHS Foundation Trust

A Translational Study of Breast-implant assocIated anaplastIc Large Cell Lymphoma and Capsular Contracture

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • The Royal Marsden NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aadil Khan, FRCS(Plast)
        • Sub-Investigator:
          • Joseph Ward, MBChB MRCS
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
BASILICA-A

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) patients recruited both retrospectively and prospectively.

Pre- and post-operative (3m and 12m) blood samples taken from prospectively recruited patients. Patients undergoing surgery + neo-adjuvant chemotherapy will be invited to donate an additional blood sample following the end of their neo-adjuvant chemotherapy.

Diagnostic pathology: Where possible fresh seroma aspirate / capsular tissue will be obtained, if not possible the FFPE embedded seroma or tissue block will be requested.

Post-operative pathological FFPE tissue samples obtained from all recruited patients.
BASILICA-C

Patients undergoing capsule related surgery (any-grade of capsular contracture, irradiated and unirradiated capsules) recruited prospectively.

Pre- and post-operative (3m) blood samples taken from all patients. Intra-operative tissue sampling (capsular washings, 2 samples of ADM and 2 samples of non-ADM capsule) from all patients.
BASILICA-N

Implant naive patients undergoing implant insertion surgery recruited prospectively.

Pre- and post-operative (3m and 12 m) blood samples taken from all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunohistochemical analysis of capsular tissue
Time Frame: 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).
3 year following final sample collection
Capsular tissue profiling using Multi-OMIC technologies
Time Frame: 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).
3 year following final sample collection
Immune profiling of peripheral blood mononuclear cells
Time Frame: 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)
3 year following final sample collection

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Aadil Khan, FRCS (Plast), Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Anticipated)

July 27, 2024

Study Completion (Anticipated)

July 27, 2024

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 23, 2021

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR5363
  • 249930 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Non-identifiable patient and translational scientific data may be shared on request with trusted scientific partners.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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