Clinical trial · Observational
Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture
A Translational Study of Breast-implant assocIated anaplastIc Large Cell Lymphoma and Capsular Contracture
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Implant-Associated Anaplastic Large Cell Lymphoma | Breast Implant-Associated Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Breast Implant; Complications | — | UNRESOLVED | — |
| Capsular Contracture, Implant | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- BASILICA-A
- description
- 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.
- label
- BASILICA-C
- description
- 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.
- label
- BASILICA-N
- description
- Implant naive patients undergoing implant insertion surgery recruited prospectively. Pre- and post-operative (3m and 12 m) blood samples taken from all patients.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available