Seroma of the Mammary Gland

NCT05899387 | Recruiting DMC

• 1 other identifier: 1.0
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Seroma; Breast Cancer; Mastectomy; Breast Implant; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

BC, mastectomy and implant

EXPERIMENTAL

Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement

Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling; Diagnostic Test: Sonographic correlation Seroma

BC and mastectomy

ACTIVE COMPARATOR

Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy

Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling; Diagnostic Test: Sonographic correlation Seroma

High risk for BC

ACTIVE COMPARATOR

healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction

Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling; Diagnostic Test: Sonographic correlation Seroma

Cosmetic breast surgery

ACTIVE COMPARATOR

healthy women planned for plastic breast implant surgery

Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling; Diagnostic Test: Sonographic correlation Seroma

Interventions

Swap collection PROCEDURE

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.

BC and mastectomy; BC, mastectomy and implant; Cosmetic breast surgery; High risk for BC

Seroma punction PROCEDURE

Puncturing of a seroma in case of occurence and clinical need

BC and mastectomy; BC, mastectomy and implant; Cosmetic breast surgery; High risk for BC

Blood sampling PROCEDURE

Blood sampling at defined time points according to protocol

BC and mastectomy; BC, mastectomy and implant; Cosmetic breast surgery; High risk for BC

Sonographic correlation Seroma DIAGNOSTIC_TEST

If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma

BC and mastectomy; BC, mastectomy and implant; Cosmetic breast surgery; High risk for BC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent
• Age ≥ 18 years
• Surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Augsburg: lead

Study Sites (1)

University Hospital Augsburg, Department of Gynecology and Obstetrics

Augsburg, Bavaria, 86156, Germany

RECRUITING

MeSH Terms

Conditions

Seroma; Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Thorsten Kühn, Prof.

  Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany

  STUDY CHAIR

• Nina Ditsch, Prof.

  University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Ditsch, Prof.

CONTACT

+49 (0)821 400 165809; nina.ditsch@uk-augsburg.de

Melitta Köpke, Dr. med.

CONTACT

+49 (0)821 400 165862; melitta.koepke@uk-augsburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: June 12, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)