Table 1.
Inclusion and exclusion criteria for the Expander-Immunology trial. (ClinicalTrials.gov ID: NCT05648929).
| inclusion criteria | exclusion criteria | ||
|---|---|---|---|
| 1 | Female sex | 1 | Sever coagulation disorder, representing a potential contraindication for the elective surgery |
| 2 | Age > 18 years | 2 | Rheumatic disease accompanied by obligatory intake of immunomodulating therapeutic agents |
| 3 | High-risk family history for breast and/or ovarian cancer and/or BRCA1/2 gene mutation carrier | 3 | Severe renal functional disorder: renal insufficiency status IV or V (estimated glomerulary filtration rate (GFR) < 30ml/min) |
| 4 | Planned bilateral mastectomy with simultaneous breast reconstruction | 4 | Active hematological or oncological disease |
| 5 | Signed informed consent form. | 5 | HIV-Infection |
| 6 | Hepatitis-Infection | ||
| 7 | Pregnancy or breast-feeding | ||
| 8 | Intake of anti-inflammatory drugs | ||
| 9 | Carrier of silicone implants (e.g. gastric banding, mammary implants) | ||