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Seroma of the Mammary Gland
RECRUITINGN/ASponsored by University Hospital Augsburg
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital Augsburg
Started2024-04-01
Est. completion2027-07-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05899387
Summary
The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.
Eligibility
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion criteria study group and control group 1: * Written informed consent * Age ≥ 18 years * all stages of DCIS or primary breast cancer (T1-T4, N0 or N+, M0) including all histopathological subtypes (ER/PR positive, ER positive/PR negative, Her-2/neu positive and triple negative) * Surgical procedure planned including ablatio or subcutaneous mastectomy with implant or expander insertion Inclusion criteria control group 2 and 3: * Written informed consent * Age ≥ 18 years * Surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy Exclusion criteria: * Age \<18 years * Male sex * Breast cancer patients planned for breast conserving therapy * Recurrent breast cancer disease * History of breast surgery * Diagnosis of LCIS only * Pregnancy at time of diagnosis * Patients with a known immunodeficiency
Conditions5
Breast CancerBreast Implant; ComplicationsCancerMastectomySeroma
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Actively Recruiting
PhaseN/A
SponsorUniversity Hospital Augsburg
Started2024-04-01
Est. completion2027-07-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05899387