Breast Implant-Associated Anaplastic Large Cell LymphomaBASILICANCT05017337
Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture
An observational study of Breast Implant-Associated Anaplastic Large Cell Lymphoma and Capsular Contracture, Implant, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Breast Implant-Associated Anaplastic Large Cell Lymphoma, Capsular Contracture, Implant, Breast Implant; Complications
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 27 Jul 2021to 27 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- Patients aged > 16 years
- Any patient with histopathologically-confirmed ALCL
- MDT recommendation for capsulectomy
- Patient consent for capsulectomy
- Patients aged > 16 years
- Any patient with a capsule arising around an implant, or a clinical diagnosis of capsular contracture
Show all 10Show fewer
- MDT recommendation for capsulectomy
- Patient consent for capsulectomy
- Patients aged > 16 years
- Any patient undergoing implant insertion surgery
Who cannot join
- Inability to give informed consent
- MDT unable to make recommendation for surgery
- BASILICA-C
- Inability to give informed consent
- MDT unable to make recommendation for surgery#
- More than one previous implant exchange, or previous extensive capsular surgery
Show all 10Show fewer
- BASILICA-N
- Inability to give informed consent
- MDT unable to make recommendation for surgery
- Previous implant insertion surgery
Trial locations and contacts
2 sites in 1 country.
Aadil Khan, FRCS (Plast) contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
Ann Gandolfi, 02086613903, ann.gandolfi@rmh.nhs.uk
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Joseph Ward, MBChB MRCS, 020 7352 8171, basilicastudy@rmh.nhs.uk
Aadil Khan, FRCS(Plast), 020 7352 8171, aadil.khan@rmh.nhs.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Implant-Associated Anaplastic Large Cell Lymphoma, Capsular Contracture, Implant, Breast Implant; Complications
- Keywords
- BIA-ALCL, Capsular Contracture, Silicone Breast Implants
- Medical subject headings
- Implant Capsular Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 3 year following final sample collection
Secondary outcomes (1)
Appraisal of patient clinical characteristics
Correlate demographic and clinical characteristics of biobank donors with translational scientific dataset (BASILICA A, C and N)
Measured: 3 year following final sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start27 Jul 2021
- Primary completion27 Jul 2024 (estimated)
- Study completion27 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant-Associated Anaplastic Large Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aadil Khan, FRCS (Plast), Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017337
- Sponsor's protocol ID
- CCR5363
- Other IDs
- 249930
- Acronym
- BASILICA
- Status last verified
- Jan 2023
- First submitted
- 12 Aug 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non-identifiable patient and translational scientific data may be shared on request with trusted scientific partners.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Study of Breast-implant assocIated anaplastIc Large Cell Lymphoma and Capsular Contracture
- ClinicalTrials.gov ID
- NCT05017337
- Acronym / sponsor ID
- BASILICA / CCR5363
- Conditions
- Breast Implant-Associated Anaplastic Large Cell Lymphoma, Capsular Contracture, Implant, Breast Implant; Complications
- Keywords
- BIA-ALCL, Capsular Contracture, Silicone Breast Implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 27 Jul 2024 (estimated)
- Study completion
- 27 Jul 2024 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (10 listed)
- Patients aged > 16 years
- Any patient with histopathologically-confirmed ALCL
- MDT recommendation for capsulectomy
- Patient consent for capsulectomy
- Patients aged > 16 years
Key exclusion criteria (10 listed)
- Inability to give informed consent
- MDT unable to make recommendation for surgery
- BASILICA-C
- Inability to give informed consent
- MDT unable to make recommendation for surgery#
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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)
1 secondary outcome
Appraisal of patient clinical characteristics
Time frame: 3 year following final sample collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No. Non-identifiable patient and translational scientific data may be shared on request with trusted scientific partners.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aadil Khan, FRCS (Plast) contact
Aadil Khan, FRCS (Plast) principal investigator
Royal Marsden NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant-Associated Anaplastic Large Cell Lymphoma and Capsular Contracture, Implant, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Ward, MBChB MRCS (02073528171, joseph.ward@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemical analysis of capsular tissue (time frame: 3 year following final sample collection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.