Clinical trial NCT05899387: Seroma of the Mammary Gland
Official title: Prospective, International, Multicenter Minimal Interventional Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Mastectomy with or Without Implant-based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Seroma
Breast Cancer
Mastectomy
Breast Implant; Complications
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Postoperative seroma formations are one of the most common and serious complications after breast surgery, above all after mastectomy. Especially in patients who have opted for breast reconstruction using implants, seromas lead to infections and wound dehiscence which can result in implant and finally breast loss. To date, the cause of seroma development has not yet been clarified. First data of a pilot study of our research group identified an association with immunological-inflammatory processes as a possible cause for seroma development (Seroma after Simple Mastectomy in Breast Cancer-The Role of CD4+ T Helper Cells and the Evidence as a Possible Specific Immune Process; Pochert et al. 2022).

The main objective of the SerMa (Seroma of the Mammary gland) study presented here is to identify patient groups who have an increased risk of developing seromas based on immunological/inflammatory processes. Based on the findings clinical consequences should be developed in the future, such as more precise risk-adapted patient education and individualized advising regarding the selection of the reconstruction procedure, with the goal of minimizing complication rates. In addition, analyses of the tumor and the microenvironment will be performed to differentiate possible carcinoma-specific immunological processes.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of a patient population at increased risk for developing seroma.
timeFrame: Follow-up for each participant: 6 month
Secondary outcomes:
measure: Comparison of findings in local and systemic measurements in patients with and without seroma.
timeFrame: Follow-up for each participant: 6 month
measure: Comparison of the groups with or without cancer regarding development of seroma.
timeFrame: Follow-up for each participant: 6 month
measure: Comparison of the clinicopathologic differences between the implant and simple mastectomy group within both cancer groups
timeFrame: Follow-up for each participant: 6 month
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg, Department of Gynecology and Obstetrics
state: Bayern
Study officials:
affiliation: Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany
name: Thorsten Kühn, Prof.
role: STUDY_CHAIR
affiliation: University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany
name: Nina Ditsch, Prof.
role: PRINCIPAL_INVESTIGATOR
References: