Lymphoma of the breast
Conditions
Interventions
None listed
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: silicone breast implant BIA-ALCL diagnosis
Exclusion criteria
Exclusion criteria: Women that do not speak Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In both BIA-ALCL cases with a history of SBI and in age-matched controls with SBI, but without ALCL, we will assess highest completed education, smoking status, alcohol consumption, body-mass index, number of pregnancies (before and after breast implants), breast feeding, age at first pregnancy, number of terminated pregnancies, medical history and family history of breast cancer and autoimmune disease, type of implant, complications after surgery (infections, re-operations, capsular contractures), history of using immunosuppressing drugs or chemotherapy and re-operations Nonspecific symptoms to be investigated will be that have been associated with the entity BII; fatigue, cognitive difficulties, joint pain, muscle pain, anxiety, feeling depressed, memory loss, skin rashes, sore and aching joints, weakness, sleeping problems, headache, hair loss, sudden food intolerances and allergies numbness and tingling in upper and lower limbs, dry eyes, morning stiffness, nights sweats, heart palpitations and shoulder pain. The association of BIA-ALCL risk with 654,027 SNP markers covering all relevant immunological, cancer-associated and other regions and genes will be analysed. BRCA1/2 and other breast cancer associated genes and HLA genes will be analysed. Associations found with GWAS study will be expressed in the form of a polygenic risk score (PRS) in order to better enable validation of our results in subsequent international studies. GWAS analysis will be performed in cases and controls | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess lymphoma-specific survival in BIA-ALCL cases. 2. To assess the median time between SBI implantation and diagnosis of BIA-ALCL. Subsequently we will investigate whether risk factor associations assessed under aim 1. vary between ALCL cases with a short and long interval between implantation and ALCL diagnosis, and between young and older women at diagnosis of BIA-ALCL. 3. To assess the delay in diagnosis of BIA-ALCL and the association thereof with risk factors mentioned in primary aim 1. | — |
Countries
Netherlands
Outcome results
None listed