Prevalence of genetic risk constellations for breast cancer in women with BIA-ALCL (Breast-Implant-Associated Anaplastic Large Cell Lymphoma)

Prevalence of genetic risk constellations for breast cancer in women with BIA-ALCL (Breast-Implant-Associated Anaplastic Large Cell Lymphoma) - BIA-ALCL Genetics

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036448

Enrollment

Registered

2026-01-16

Start date

2026-01-16

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C84.7

Interventions

Group 1: Women with BIA-ALCL Findings: Anamnestic data and findings on previous implant-related procedures, treatment of BIA-ALCL and the current health situation are collected. - General character

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: BIA-ALCL diagnosis

Exclusion criteria

Exclusion criteria: Patients who have not signed the declaration of consent and therefore can no longer be contacted will undergo an anonymized, retrospective survey of their treatment details, conducted by the treating institutions. Additionally, an anonymous reference pathology will be prepared, along with anonymous testing for somatic mutations in any remaining tumor material. In the case of partial, explicit rejection, the study will be limited to the approved aspects.

Design outcomes

Primary

Measure	Time frame
Number of genetic risk carriers in a German collective of BIA-ALCL patients compared to patients without familial risk. The aim of this study is to clarify the association between BIA-ALCL and genetic risk constellations for breast cancer on the basis of all cases reported to the BfArM. To determine the prevalence, the BIA-ALCL diagnosis of the patients is checked using the measurements described under ‘Arm 1’ and an examination is offered to assess their genetic risk of developing breast cancer. The prevalences of the genetic changes found in the study collective, e.g. pathogenic mutations in the BRCA1/2 genes, are compared with the prevalences of these changes in control collectives. These data from control collectives are publicly accessible and are already available. Control data do not need to be collected again. Data sources for mutation prevalences in women without the disease include gnomAD (broadinstitute.org) or FLOSSIES (whi.colour.com). In addition, we have internal control data sets at the Cologne centre (data from n=2189 women without the disease; from: Hauke et al, Gene panel testing of 5589 BRCA1/2-negative index patients with breast cancer in a routine diagnostic setting: results of the German Consortium for Hereditary Breast and Ovarian Cancer - PubMed (nih.gov)), which can be used for this project.	—

Measure

Time frame

Number of genetic risk carriers in a German collective of BIA-ALCL patients compared to patients without familial risk. The aim of this study is to clarify the association between BIA-ALCL and genetic risk constellations for breast cancer on the basis of all cases reported to the BfArM. To determine the prevalence, the BIA-ALCL diagnosis of the patients is checked using the measurements described under ‘Arm 1’ and an examination is offered to assess their genetic risk of developing breast cancer. The prevalences of the genetic changes found in the study collective, e.g. pathogenic mutations in the BRCA1/2 genes, are compared with the prevalences of these changes in control collectives. These data from control collectives are publicly accessible and are already available. Control data do not need to be collected again. Data sources for mutation prevalences in women without the disease include gnomAD (broadinstitute.org) or FLOSSIES (whi.colour.com). In addition, we have internal control data sets at the Cologne centre (data from n=2189 women without the disease; from: Hauke et al, Gene panel testing of 5589 BRCA1/2-negative index patients with breast cancer in a routine diagnostic setting: results of the German Consortium for Hereditary Breast and Ovarian Cancer - PubMed (nih.gov)), which can be used for this project.

—

Secondary

Measure	Time frame
Estimation of the risk for women with a genetic risk constellation for breast cancer to develop BIA-ALCL. Estimation of the risk depending on the type of implant used. Estimation of the post-operative stress level despite presumably curative therapy.	—

Countries

Germany

Contacts

Public ContactUwe von Fritschen

Helios Klinikum Emil von Behring GmbH

uwe.von-fritschen@helios-gesundheit.de+49 30 8102 1445

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026