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

September 25, 2023 updated by: The Lymphoma Academic Research Organisation

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Bruges, Belgium
        • Recruiting
        • A. Z. Sint-Jan Brugge-Oostende AV
        • Contact:
      • Brussel, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
      • Brussels, Belgium
        • Recruiting
        • Institut Jules Bordet
        • Contact:
      • Brussels, Belgium
      • Bruxelles, Belgium
        • Not yet recruiting
        • Cliniques Universitaires de Bruxelles - Hôpital Erasme
        • Contact:
      • Edegem, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
      • Gent, Belgium
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
      • Leuven, Belgium
        • Recruiting
        • U.Z. Leuven - Campus Gasthuisberg
        • Contact:
      • Liège, Belgium
        • Recruiting
        • CHU de Liège -Domaine Sart Tilman
        • Contact:
      • Yvoir, Belgium
        • Recruiting
        • CHU UCL Namur - site Godinne
        • Contact:
  • France
      • Avignon, France
        • Recruiting
        • CH d Avignon - Hopital Henri Duffaut
        • Contact:
      • Bordeaux, France
      • Brest, France
      • Colmar, France
      • Creteil, France
        • Recruiting
        • APHP - Hopital Henri Mondor
        • Contact:
      • Dijon, France, 21034
      • Lille, France
      • Lyon, France
      • Marseille, France
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
      • Montpellier, France
      • Nantes, France
        • Recruiting
        • CHU de Nantes - Hotel Dieu
        • Contact:
          • Béatrice MAHE, MD
      • Paris, France
      • Pau, France
      • Perpignan, France
      • Pierre Bénite, France
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
      • Reims, France
        • Recruiting
        • CHU de Reims - Hôpital Robert Debré
        • Contact:
      • Rouen, France
      • Saint Cloud, France, 92210
        • Recruiting
        • Centre Rene Hugenin
        • Contact:
      • Saint-Malo, France
      • Strasbourg, France, 67100
      • Toulouse, France
        • Recruiting
        • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BIA-ALCL
Other: BIA-ALCL
Observational : no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response
Time Frame: 13 years
13 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Lymphoma Academic Research Organisation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2017

Primary Completion (Estimated)

June 7, 2032

Study Completion (Estimated)

June 7, 2032

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 6, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIA-ALCL Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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