Seroma of the Mammary Gland
Recruiting · NCT05899387 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Blood samplingSeroma punctionSonographic correlation SeromaSwap collection
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Hospital Augsburg, Department of Gynecology and Obstetrics - Augsburg, Bavaria, Germany