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Dutch female patients with breast implant associated anaplastisch large cell lymphoma


- candidate number24234
- NTR NumberNTR5799
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-apr-2016
- Secondary IDs16.0453 METC van het Antoni van Leeuwenhoek/Nederlands Kanker Instituut
- Public TitleDutch female patients with breast implant associated anaplastisch large cell lymphoma
- Scientific TitleCase-control study: Dutch female patients with breast implant associated anaplastisch large cell lymphoma
- ACRONYMCase-control study: Dutch female patients with BIA-ALCL
- hypothesisDue to the increased clinical awareness concerning the subject of BIA-ALCL, we expect to report a higher incidence of this disease anno 2015/2016
- Healt Condition(s) or Problem(s) studiedBreast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
- Inclusion criteria- Female patients with BIA-ALCL
- Female patients with a primary Non Hodgkin lymphoma in the breast
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 20-apr-2016
- planned closingdate20-jun-2017
- Target number of participants150
- InterventionsNone
- Primary outcomeEpidemiological numbers of BIA-ALCL anno 2015/2016 (incidence, relative risk)
- Secondary outcomeClinicopathological details of patients with BIA-ALCL
- TimepointsNone
- Trial web site
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES Mintsje de Boer
- CONTACT for SCIENTIFIC QUERIES Mintsje de Boer
- Sponsor/Initiator Maastricht University Medical Center (MUMC+), Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publicationsde Jong D, Vasmel WL, de Boer JP, Verhave G, Barbé E, Casparie MK, van Leeuwen FE.
Anaplastic large-cell lymphoma in women with breast implants.
JAMA 2008;300:2030–35.
- Brief summaryIn this retrospective epidemiological case-control and clinicopathological study, we identify all existing cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in the Netherlands. Amongst others, Relative and absolute risk to develop BIA-ALCL will be calculated. Also clinicopathological characteristics of the existing BIA-ALCL cases will be collected
- Main changes (audit trail)
- RECORD14-apr-2016 - 4-jun-2016


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