Seroma of the Mammary Gland

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05899387

Studienbeginn:
April 2024

Letztes Update:
08.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Seroma

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Augsburg

Collaborator:
-

Studienleiter

Thorsten Kühn, Prof.
Study Chair
Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany

Nina Ditsch, Prof.
Principal Investigator
University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany

Kontakt

Nina Ditsch, Prof.
Kontakt:
Phone: +49 (0)821 400 165809
E-Mail: nina.ditsch@uk-augsburg.de» Kontaktdaten anzeigen

Melitta Köpke, Dr. med.
Kontakt:
Phone: +49 (0)821 400 165862
E-Mail: melitta.koepke@uk-augsburg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Augsburg, Department of Gynecology and Obstetrics
86156 Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Nina Ditsch, Prof.
E-Mail: nina.ditsch@uk-agsburg.de

Melitta Köpke, Dr.
E-Mail: melitta.koepke@uk-augsburg.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Identification of a patient population at increased risk for developing seroma. (Time Frame - Follow-up for each participant: 6 month):
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.

Secondary outcome:

1. Comparison of findings in local and systemic measurements in patients with and without seroma. (Time Frame - Follow-up for each participant: 6 month)

2. Comparison of the groups with or without cancer regarding development of seroma. (Time Frame - Follow-up for each participant: 6 month)

3. Comparison of the clinicopathologic differences between the implant and simple mastectomy group within both cancer groups (Time Frame - Follow-up for each participant: 6 month)

Studien-Arme

BC, mastectomy and implant
Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement
BC and mastectomy
Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy
High risk for BC
healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction
Cosmetic breast surgery
healthy women planned for plastic breast implant surgery

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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