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

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ClinicalTrials.gov Identifier: NCT04220970
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : July 26, 2021
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

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


Condition or disease Intervention/treatment
Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL) Other: BIA-ALCL

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 13 Years
Official Title: Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : June 7, 2032
Estimated Study Completion Date : June 7, 2032


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




Primary Outcome Measures :
  1. Overall response [ Time Frame: 13 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female with Breast implants
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with an anaplastic large cell lymphoma associated with breast implants
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220970


Contacts
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Contact: Manon Croix +33 (04) 72 66 93 33 manon.croix.ext@lysarc.org

Locations
Show Show 31 study locations
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
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Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT04220970    
Other Study ID Numbers: BIA-ALCL Registry
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Lymphoma Academic Research Organisation:
BIA-ALCL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell