Seroma of the Mammary Gland

Trial Title: Seroma of the Mammary Gland

NCT ID: NCT05899387

Condition: Seroma
Breast Cancer
Mastectomy
Breast Implant; Complications

Conditions: Official terms:
Seroma

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Swap collection
Description: 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.
Arm group label: BC and mastectomy
Arm group label: BC, mastectomy and implant
Arm group label: Cosmetic breast surgery
Arm group label: High risk for BC

Intervention type: Procedure
Intervention name: Seroma punction
Description: Puncturing of a seroma in case of occurence and clinical need
Arm group label: BC and mastectomy
Arm group label: BC, mastectomy and implant
Arm group label: Cosmetic breast surgery
Arm group label: High risk for BC

Intervention type: Procedure
Intervention name: Blood sampling
Description: Blood sampling at defined time points according to protocol
Arm group label: BC and mastectomy
Arm group label: BC, mastectomy and implant
Arm group label: Cosmetic breast surgery
Arm group label: High risk for BC

Summary: 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: 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.

Criteria for eligibility:

Study pop:
The study is divided into four groups, of which the first is the study group and the other three are the control groups. Recruitment is planned prospectively in participating study sites. All patients planned for the procedures in accordance to the protocol should be informed about the possibility to participate in the SerMa study.

Sampling method: Non-Probability Sample
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University Hospital Augsburg, Department of Gynecology and Obstetrics

Address:
City: Augsburg
Zip: 86156
Country: Germany

Status: Recruiting

Contact:
Last name: Nina Ditsch, Prof.
Email: nina.ditsch@uk-agsburg.de

Contact backup:
Last name: Melitta Köpke, Dr.
Email: melitta.koepke@uk-augsburg.de

Start date: April 1, 2024

Completion date: July 1, 2027

Lead sponsor:
Agency: University Hospital Augsburg
Agency class: Other

Source: University Hospital Augsburg

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05899387