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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04220970
Other study ID # BIA-ALCL Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 7, 2017
Est. completion date June 7, 2032

Study information

Verified date September 2023
Source The Lymphoma Academic Research Organisation
Contact Manon Croix
Phone +33 (04) 72 66 93 33
Email manon.croix.ext@lysarc.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 7, 2032
Est. primary completion date June 7, 2032
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with an anaplastic large cell lymphoma associated with breast implants Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
BIA-ALCL
Observational : no intervention

Locations

Country Name City State
Belgium A. Z. Sint-Jan Brugge-Oostende AV Bruges
Belgium Universitair Ziekenhuis Brussel Brussel
Belgium Clinique Universitaire Saint LUC Brussels
Belgium Institut Jules Bordet Brussels
Belgium Cliniques Universitaires de Bruxelles - Hôpital Erasme Bruxelles
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium Universitair Ziekenhuis Gent Gent
Belgium U.Z. Leuven - Campus Gasthuisberg Leuven
Belgium CHU de Liège -Domaine Sart Tilman Liège
Belgium CHU UCL Namur - Site Godinne Yvoir
France CH d Avignon - Hopital Henri Duffaut Avignon
France Institut Bergonié Bordeaux
France CHRU de Brest - Hôpital Morvan Brest
France Hopital Louis Pasteur Colmar
France APHP - Hopital Henri Mondor Creteil
France CHU de Dijon - Hôpital le Bocage Dijon
France Centre Médical la Roseraie Lille
France Centre Léon Bérard Lyon
France Institut Paoli Calmettes Marseille
France CH Saint-Eloi Montpellier
France CHU de Nantes - Hôtel Dieu Nantes
France Hôpital Cochin Paris
France CH de Pau Pau
France CH de Perpigan Perpignan
France Centre Hospitalier Lyon Sud Pierre Bénite
France Chu de Reims - Hopital Robert Debre Reims
France Centre Henri Becquerel Rouen
France Centre Rene Hugenin Saint Cloud
France CH de Saint Malo Saint-Malo
France CHRU de Strasbourg Strasbourg
France Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) Toulouse

Sponsors (1)

Lead Sponsor Collaborator
The Lymphoma Academic Research Organisation

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response 13 years