Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture

NCT05017337 | Unknown

• 2 other identifiers: CCR5363249930
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

BIA-ALCL; Capsular Contracture; Silicone Breast Implants

Outcome Measures

Primary Outcomes (3)

• Immunohistochemical analysis of capsular tissue

  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

  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

  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 Outcomes (1)

• Appraisal of patient clinical characteristics

  3 year following final sample collection

Study Arms (3)

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.

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Patients aged \> 16 years
• Any patient with histopathologically-confirmed ALCL
• MDT recommendation for capsulectomy
• Patient consent for capsulectomy

You may not qualify if:

• Inability to give informed consent
• MDT unable to make recommendation for surgery
• BASILICA-C
• Patients aged \> 16 years
• Any patient with a capsule arising around an implant, or a clinical diagnosis of capsular contracture
• MDT recommendation for capsulectomy
• Patient consent for capsulectomy
• Inability to give informed consent
• MDT unable to make recommendation for surgery#
• More than one previous implant exchange, or previous extensive capsular surgery
• BASILICA-N
• Patients aged \> 16 years
• Any patient undergoing implant insertion surgery
• Inability to give informed consent
• MDT unable to make recommendation for surgery

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (2)

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Pre- and post-operative blood samples (BASILICA-A prospective, BASILICA-C, BASILICA-N); Capsular tissue samples (BASILICA-C: intra-operative tissue sampling, BASILICA-A retrospective: pathological FFPE blocks); Capsular Washings (BASILICA-C only)

MeSH Terms

Conditions

Implant Capsular Contracture

Condition Hierarchy (Ancestors)

Foreign-Body Reaction; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prosthesis Failure; Postoperative Complications

Study Officials

• Aadil Khan, FRCS (Plast)

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Ward, MBChB MRCS

CONTACT

02073528171; joseph.ward@icr.ac.uk

Aadil Khan, FRCS (Plast)

CONTACT

aadil.khan@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 23, 2021
• Study Start: July 27, 2021
• Primary Completion: July 27, 2024
• Study Completion: July 27, 2024
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)