Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry
Sponsor
The Lymphoma Academic Research Organisation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04220970
Collaborator
(none)
150
31
180
4.8
0
Study Details
Study Description
Brief 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 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
150 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry
Actual Study Start Date
:
Jun 7, 2017
Anticipated Primary Completion Date
:
Jun 7, 2032
Anticipated Study Completion Date
:
Jun 7, 2032
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| BIA-ALCL
|
Other: BIA-ALCL
Observational : no intervention
|
Outcome Measures
Primary Outcome Measures
- Overall response [13 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Adult patients with an anaplastic large cell lymphoma associated with breast implants
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | A. Z. Sint-Jan Brugge-Oostende AV | Bruges | Belgium | ||
| 2 | Clinique Universitaire Saint LUC | Brussels | Belgium | ||
| 3 | Institut Jules Bordet | Brussels | Belgium | ||
| 4 | Universitair Ziekenhuis Brussel | Brussel | Belgium | ||
| 5 | Cliniques Universitaires de Bruxelles - Hôpital Erasme | Bruxelles | Belgium | ||
| 6 | Universitair Ziekenhuis Antwerpen | Edegem | Belgium | ||
| 7 | Universitair Ziekenhuis Gent | Gent | Belgium | ||
| 8 | U.Z. Leuven - Campus Gasthuisberg | Leuven | Belgium | ||
| 9 | CHU de Liège -Domaine Sart Tilman | Liège | Belgium | ||
| 10 | CHU UCL Namur - Site Godinne | Yvoir | Belgium | ||
| 11 | CH d Avignon - Hopital Henri Duffaut | Avignon | France | ||
| 12 | Institut Bergonié | Bordeaux | France | ||
| 13 | CHRU de Brest - Hôpital Morvan | Brest | France | ||
| 14 | Hopital Louis Pasteur | Colmar | France | ||
| 15 | APHP - Hopital Henri Mondor | Creteil | France | ||
| 16 | CHU de Dijon - Hôpital le Bocage | Dijon | France | 21034 | |
| 17 | Centre Médical la Roseraie | Lille | France | ||
| 18 | Centre Léon Bérard | Lyon | France | ||
| 19 | Institut Paoli Calmettes | Marseille | France | ||
| 20 | CH Saint-Eloi | Montpellier | France | ||
| 21 | CHU de Nantes - Hôtel Dieu | Nantes | France | ||
| 22 | Hôpital Cochin | Paris | France | ||
| 23 | CH de Pau | Pau | France | ||
| 24 | CH de Perpigan | Perpignan | France | ||
| 25 | Centre Hospitalier Lyon Sud | Pierre Bénite | France | ||
| 26 | Chu de Reims - Hopital Robert Debre | Reims | France | ||
| 27 | Centre Henri Becquerel | Rouen | France | ||
| 28 | Centre Rene Hugenin | Saint Cloud | France | 92210 | |
| 29 | CH de Saint Malo | Saint-Malo | France | ||
| 30 | CHRU de Strasbourg | Strasbourg | France | 67100 | |
| 31 | Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) | Toulouse | France |
Sponsors and Collaborators
- The Lymphoma Academic Research Organisation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier:
NCT04220970
Other Study ID Numbers:
- BIA-ALCL Registry
First Posted:
Jan 7, 2020
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Lymphoma Academic Research Organisation
Additional relevant MeSH terms: