Clinical trial NCT04220970: Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry
Official title: Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)
Keywords: BIA-ALCL
Lead sponsor: The Lymphoma Academic Research Organisation
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with an anaplastic large cell lymphoma associated with breast implants

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


Eligibility criteria: Inclusion Criteria:

* Adult patients with an anaplastic large cell lymphoma associated with breast implants

Exclusion Criteria:

-

Primary outcomes:
measure: Overall response
timeFrame: 13 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: A. Z. Sint-Jan Brugge-Oostende AV
city: Brussels
country: Belgium
facility: Clinique Universitaire Saint LUC
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: U.Z. Leuven - Campus Gasthuisberg
city: Liège
country: Belgium
facility: CHU de Liège -Domaine Sart Tilman
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
city: Avignon
country: France
facility: CH d Avignon - Hopital Henri Duffaut
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: CHRU de Brest - Hôpital Morvan
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Creteil
country: France
facility: APHP - Hopital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon - Hôpital le Bocage
city: Lille
country: France
facility: Centre Médical la Roseraie
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: CH Saint-Eloi
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Paris
country: France
facility: Hôpital Cochin
city: Pau
country: France
facility: CH de Pau
city: Perpignan
country: France
facility: CH de Perpigan
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Chu de Reims - Hopital Robert Debre
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Cloud
country: France
facility: Centre Rene Hugenin
city: Saint-Malo
country: France
facility: CH de Saint Malo
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
Study officials:
References: