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Recruiting NCT04220970

Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry

Observational Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BIA-ALCL.
Who it may be relevant to
Registry conditions: Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Other BIA-ALCL
    Observational : no intervention

Primary outcome measures

  • Overall response [Time frame: 13 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 21 centers
  • CH d Avignon - Hopital Henri Duffaut — Avignon
  • Institut Bergonié — Bordeaux
  • CHRU de Brest - Hôpital Morvan — Brest
  • Hopital Louis Pasteur — Colmar
  • APHP - Hopital Henri Mondor — Créteil
  • CHU de Dijon - Hôpital le Bocage — Dijon
  • Centre Médical la Roseraie — Lille
  • Centre Léon Bérard — Lyon
  • … and 13 more centers
Belgium · 10 centers
  • A. Z. Sint-Jan Brugge-Oostende AV — Bruges
  • Clinique Universitaire Saint LUC — Brussels
  • Cliniques Universitaires de Bruxelles - Hôpital Erasme — Brussels
  • Institut Jules Bordet — Brussels
  • Universitair Ziekenhuis Brussel — Brussels
  • Universitair Ziekenhuis Antwerpen — Edegem
  • Universitair Ziekenhuis Gent — Ghent
  • U.Z. Leuven - Campus Gasthuisberg — Leuven
  • … and 2 more centers

Identifiers

NCT: NCT04220970 · BIA-ALCL Registry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗