NCT04220970

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
74mo left

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
2 countries

31 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2017Jun 2032

Study Start

First participant enrolled

June 7, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2032

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

15 years

First QC Date

January 6, 2020

Last Update Submit

January 12, 2026

Conditions

Keywords

BIA-ALCL

Outcome Measures

Primary Outcomes (1)

  • Overall response

    13 years

Study Arms (1)

BIA-ALCL

Other: BIA-ALCL

Interventions

Observational : no intervention

BIA-ALCL

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale with Breast implants
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

A. Z. Sint-Jan Brugge-Oostende AV

Bruges, Belgium

RECRUITING

Clinique Universitaire Saint LUC

Brussels, Belgium

RECRUITING

Cliniques Universitaires de Bruxelles - Hôpital Erasme

Brussels, Belgium

NOT YET RECRUITING

Institut Jules Bordet

Brussels, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Brussels, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Gent

Ghent, Belgium

RECRUITING

U.Z. Leuven - Campus Gasthuisberg

Leuven, Belgium

RECRUITING

CHU de Liège -Domaine Sart Tilman

Liège, Belgium

RECRUITING

CHU UCL Namur - Site Godinne

Yvoir, Belgium

RECRUITING

CH d Avignon - Hopital Henri Duffaut

Avignon, France

RECRUITING

Institut Bergonié

Bordeaux, France

RECRUITING

CHRU de Brest - Hôpital Morvan

Brest, France

RECRUITING

Hopital Louis Pasteur

Colmar, France

RECRUITING

APHP - Hopital Henri Mondor

Créteil, France

RECRUITING

CHU de Dijon - Hôpital le Bocage

Dijon, 21034, France

RECRUITING

Centre Médical la Roseraie

Lille, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Institut Paoli Calmettes

Marseille, France

RECRUITING

CH Saint-Eloi

Montpellier, France

RECRUITING

CHU de Nantes - Hôtel Dieu

Nantes, France

RECRUITING

Hôpital Cochin

Paris, France

RECRUITING

CH de Pau

Pau, France

RECRUITING

CH de Perpigan

Perpignan, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

Chu de Reims - Hopital Robert Debre

Reims, France

RECRUITING

Centre Henri Becquerel

Rouen, France

RECRUITING

Centre Rene Hugenin

Saint-Cloud, 92210, France

RECRUITING

CH de Saint Malo

St-Malo, France

RECRUITING

CHRU de Strasbourg

Strasbourg, 67100, France

RECRUITING

Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

Toulouse, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
13 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 7, 2020

Study Start

June 7, 2017

Primary Completion (Estimated)

June 7, 2032

Study Completion (Estimated)

June 7, 2032

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations