Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)NCT04220970
Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry
An observational study of Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL), run by The Lymphoma Academic Research Organisation at 31 sites in 2 countries.
Trial summary
Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant. Because of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)
- What is being tested?
- BIA-ALCL
- How many people
- 150 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 7 Jun 2017to 7 Jun 2032
- How long will I take part?
- 13 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with an anaplastic large cell lymphoma associated with breast implants
Who may be able to join
- Adult patients with an anaplastic large cell lymphoma associated with breast implants
Who cannot join
- -
Trial locations and contacts
31 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 2 countries
France21 sites, 21 recruiting
- Recruiting
CH d Avignon - Hopital Henri Duffaut
Avignon
Borhane SLAMA, MD, 04 32 75 93 00, bslama@ch-avignon.fr
- Recruiting
Institut Bergonié
Bordeaux
Fontanet BIJOU, MD, +33 05 56 33 78 32, f.bijou@bordeaux.unicancer.fr
- Recruiting
CHRU de Brest - Hôpital Morvan
Brest
Adrian TEMPESCUL, MD, 02 98 22 33 95, adrian.tempescul@chu-brest.fr
- Recruiting
Hopital Louis Pasteur
Colmar
Bruno AUDHUY, MD, 0389124104, bruno.audhuy@ch-colmar.rss.fr
- Recruiting
APHP - Hopital Henri Mondor
Créteil
Corinne HAIOUN, MD, 01 49 81 21 11, corinne.haioun@hmn.aphp.fr
- Recruiting
CHU de Dijon - Hôpital le Bocage
Dijon, 21034
Jean-Noel BASTIE, MD, 03 80 29 50 41, jean-noel.bastie@chu-dijon.fr
- Recruiting
Centre Médical la Roseraie
Lille
Manuel CLIQUENNOIS, MD, 0320994055, cliquennois@maladiesdusang.fr
- Recruiting
Centre Léon Bérard
Lyon
Emmanuelle NICOLAS-VIRELIZIER, MD, 04 78 78 28 28, emmanuelle.nicolas@lyon.unicancer.fr
- Recruiting
Institut Paoli Calmettes
Marseille
Jean Marc SCHIANO, MD, 04 91 22 33 33, schianojm@ipc.unicancer.fr
- Recruiting
CH Saint-Eloi
Montpellier
Guillaume CARTRON, MD, +33(0)4 67 33 83 62, guillaume.cartron@orange.fr
- Recruiting
CHU de Nantes - Hôtel Dieu
Nantes
Béatrice MAHE, MD
- Recruiting
Hôpital Cochin
Paris
Bénédicte DEAU FISCHER, MD, +33(0)158412132, benedicte.deau-fischer@cch.aphp.fr
- Recruiting
CH de Pau
Pau
Marcela ANITEI GHINEA, MD, 05 59 72 67 96, marcela.anitei@ch-pau.fr
- Recruiting
CH de Perpigan
Perpignan
Laurence SANHES, MD, 04 68 61 89 07, laurence.sanhes@ch-perpignan.fr
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite
Gilles SALLES, MD, 04 78 86 43 40, gilles.salles@chu-lyon.fr
- Recruiting
Chu de Reims - Hopital Robert Debre
Reims
Eric DUROT, MD, +33(0)3 26 78 36 44, edurot@chu-reims.fr
- Recruiting
Centre Henri Becquerel
Rouen
Fabrice JARDIN, MD, +33 (0)2 32 08 29 09, fabrice.jardin@chb.unicancer.fr
- Recruiting
Centre Rene Hugenin
Saint-Cloud, 92210
Sylvie GLAISNER, MD, +33(0)1 47 11 15 15, sylvie.glaisner@curie.net
- Recruiting
CH de Saint Malo
St-Malo
Claudia BIRLADEANU, 02 99 21 21 50, C.BIRLADEANU@ch-stmalo.fr
- Recruiting
CHRU de Strasbourg
Strasbourg, 67100
Elise TOUSSAINT, MD, 03 88 11 67 28, elise.toussaint@chru-strasbourg.fr
- Recruiting
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
Toulouse
Lucie Oberic, Dr, +33(0)561777666, oberic.l@chu-toulouse.fr
Belgium10 sites, 10 recruiting
- Recruiting
A. Z. Sint-Jan Brugge-Oostende AV
Bruges
Sylvia SNAUWAERT, MD, +32 (0)50 45 23 28, sylvia.snauwaert@azsintjan.be
- Recruiting
Clinique Universitaire Saint LUC
Brussels
Nicole STRAETMANS, MD, 02 764 18 00, nicole.straetmans@uclouvain.be
- Not yet recruiting
Cliniques Universitaires de Bruxelles - Hôpital Erasme
Brussels
Virginie DE WILDE, MD, +32 2 555 31 11, virginie.de.wilde@erasme.ulb.ac.be
- Recruiting
Institut Jules Bordet
Brussels
Marie MAEREVOET, MD, +32 2 541 31 11, marie.maerevoet@bordet.be
- Not yet recruiting
Universitair Ziekenhuis Brussel
Brussels
Rik SCHOTS, MD, 02 477 41 11, rik.schots@uzbrussel.be
- Not yet recruiting
Universitair Ziekenhuis Antwerpen
Edegem
Wilfried SCHROYENS, MD, +32 3 821 53 98, Wilfried.Schroyens@uza.be
- Recruiting
Universitair Ziekenhuis Gent
Ghent
Fritz OFFNER, MD, +32(0)92402138, fritz.offner@ugent.be
- Recruiting
U.Z. Leuven - Campus Gasthuisberg
Leuven
Ann JANSSENS, MD, +32 16 34 66 70, ann.janssens@uzleuven.be
- Recruiting
CHU de Liège -Domaine Sart Tilman
Liège
Christophe BONNET, MD, +32(0)43662851, cbonnet@ulg.ac.be
- Recruiting
CHU UCL Namur - Site Godinne
Yvoir
Marc ANDRE, MD, 081/42 38 31, marc.andre@uclouvain.be
About this study
Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant.
Because of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the implementation of a BIA-ALCL case registry, in connection with a national Multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire nationale de recours- RCP).
This registry is opened in France and in Belgium
- Being tested
- BIA-ALCL
- Keywords
- BIA-ALCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA-ALCLOther
Observational : no intervention
| Study group | Role | What they receive |
|---|---|---|
| BIA-ALCL | Not described Receives: Other: BIA-ALCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response
Measured: 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start7 Jun 2017
- Primary completion7 Jun 2032 (estimated)
- Study completion7 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)Studies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 150 participants (estimated)
- Target duration
- 13 Years
Sponsor and investigators
- Lead sponsor
- The Lymphoma Academic Research Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220970
- Sponsor's protocol ID
- BIA-ALCL Registry
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2020
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry
- ClinicalTrials.gov ID
- NCT04220970
- Acronym / sponsor ID
- BIA-ALCL Registry
- Keywords
- BIA-ALCL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Lymphoma Academic Research OrganisationUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 7 Jun 2032 (estimated)
- Study completion
- 7 Jun 2032 (estimated)
- First posted
- 7 Jan 2020 (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.
Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant.
Because of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the implementation of a BIA-ALCL case registry, in connection with a national Multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire nationale de recours- RCP).
This registry is opened in France and in Belgium
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 13 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIA-ALCL | – | Other: BIA-ALCL |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with an anaplastic large cell lymphoma associated with breast implants
Key inclusion criteria (1 listed)
- Adult patients with an anaplastic large cell lymphoma associated with breast implants
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIA-ALCLObservational : no intervention | Other | BIA-ALCL |
Primary outcome
Overall response
Time frame: 13 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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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.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL), run by The Lymphoma Academic Research Organisation at 31 sites in 2 countries.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon Croix (+33 (04) 72 66 93 33, manon.croix.ext@lysarc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (time frame: 13 years). 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 14 Jan 2026.