Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2024-04-01
2027-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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BC, mastectomy and implant
Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement
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
Sonographic correlation Seroma
If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma
BC and mastectomy
Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy
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
Sonographic correlation Seroma
If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma
High risk for BC
healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction
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
Sonographic correlation Seroma
If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma
Cosmetic breast surgery
healthy women planned for plastic breast implant surgery
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
Sonographic correlation Seroma
If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma
Interventions
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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
Sonographic correlation Seroma
If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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University Hospital Augsburg
OTHER
Responsible Party
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Nina Ditsch
Prof. Dr. med.
Principal Investigators
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Thorsten Kühn, Prof.
Role: STUDY_CHAIR
Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany
Nina Ditsch, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany
Locations
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University Hospital Augsburg, Department of Gynecology and Obstetrics
Augsburg, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1.0
Identifier Type: -
Identifier Source: org_study_id
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