Seroma of the Mammary Gland

Breast Cancer Clinical Trial

— SerMa  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899387
• Other study ID #: 1.0
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: April 2024
• Source: University Hospital Augsburg
• Contact: Nina Ditsch, Prof.
• Phone: +49 (0)821 400 165809
• Email: nina.ditsch[@]uk-augsburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Implant; Complications
• Mastectomy
• Seroma

Intervention

Procedure:
• Swap collection
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.
• Seroma punction
Puncturing of a seroma in case of occurence and clinical need
• Blood sampling
Blood sampling at defined time points according to protocol

Locations

Country	Name	City	State
Germany	University Hospital Augsburg, Department of Gynecology and Obstetrics	Augsburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

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