Seroma of the Mammary Gland

Study Overview
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Brief Summary
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The study is designed as international, prospective, multicenter non-AMG/MPG 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
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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.

Official Title
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Prospective, International, Multicenter Non-AMG/MPG Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Skin-sparing Mastectomy and Implant Breast Reconstruction

Conditions
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Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications

Intervention / Treatment
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* Procedure: Swap collection
* Procedure: Seroma punction
* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BC, mastectomy and implant<br>Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement | Procedure: Swap collection<br>* Performing the surgery (Mastectomy with or without implant reconstruction; Insertion of Breast implants for control group 3) according to valid standards. In addition, taking swabs intraoperatively according to protocol from skin and surgical site.<br>Procedure: Seroma punction<br>* Puncturing of a seroma in case of occurence and clinical need<br>Procedure: Blood sampling<br>* Blood sampling at defined time points according to protocol<br>|
| BC and mastectomy<br>Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy | Procedure: Swap collection<br>* Performing the surgery (Mastectomy with or without implant reconstruction; Insertion of Breast implants for control group 3) according to valid standards. In addition, taking swabs intraoperatively according to protocol from skin and surgical site.<br>Procedure: Seroma punction<br>* Puncturing of a seroma in case of occurence and clinical need<br>Procedure: Blood sampling<br>* Blood sampling at defined time points according to protocol<br>|
| High risk for BC<br>healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction | Procedure: Swap collection<br>* Performing the surgery (Mastectomy with or without implant reconstruction; Insertion of Breast implants for control group 3) according to valid standards. In addition, taking swabs intraoperatively according to protocol from skin and surgical site.<br>Procedure: Seroma punction<br>* Puncturing of a seroma in case of occurence and clinical need<br>Procedure: Blood sampling<br>* Blood sampling at defined time points according to protocol<br>|
| Cosmetic breast surgery<br>healthy women planned for plastic breast implant surgery | Procedure: Swap collection<br>* Performing the surgery (Mastectomy with or without implant reconstruction; Insertion of Breast implants for control group 3) according to valid standards. In addition, taking swabs intraoperatively according to protocol from skin and surgical site.<br>Procedure: Seroma punction<br>* Puncturing of a seroma in case of occurence and clinical need<br>Procedure: Blood sampling<br>* Blood sampling at defined time points according to protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of a patient population at increased risk for developing seroma. | Examination of seroma fluid and blood samples to identify immunological markers. Local microbiome analyses to investigate a possible bacterial colonization. Tissue analyses to determine possible carcinoma-specific immunologic processes. | Follow-up for each participant: 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of findings in local and systemic measurements in patients with and without seroma. |  | Follow-up for each participant: 6 month | 
| Comparison of the groups with or without cancer regarding development of seroma. |  | Follow-up for each participant: 6 month | 
| Comparison of the clinicopathologic differences between the implant and simple mastectomy group within both cancer groups |  | Follow-up for each participant: 6 month |