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Идёт набор NCT05899387

Seroma of the Mammary Gland

Без фазы С лечением Seroma Breast Cancer Mastectomy Breast Implant; Complications

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Swap collection, Seroma punction, Blood sampling, Sonographic correlation Seroma.
Кому может быть актуально
Состояния в реестре: Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective, International, Multicenter Minimal Interventional Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Mastectomy with or Without Implant-based Breast Reconstruction

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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.
  • Процедура Seroma punction
    Puncturing of a seroma in case of occurence and clinical need
  • Процедура Blood sampling
    Blood sampling at defined time points according to protocol
  • Диагностический тест Sonographic correlation Seroma
    If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma

Первичные конечные точки

  • Identification of a patient population at increased risk for developing seroma. [Срок оценки: Follow-up for each participant: 6 month]
Вторичные конечные точки (3)
  • Comparison of findings in local and systemic measurements in patients with and without seroma. [Срок оценки: Follow-up for each participant: 6 month]
  • Comparison of the groups with or without cancer regarding development of seroma. [Срок оценки: Follow-up for each participant: 6 month]
  • Comparison of the clinicopathologic differences between the implant and simple mastectomy group within both cancer groups [Срок оценки: Follow-up for each participant: 6 month]

Критерии участия

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Германия · 1 центр
  • University Hospital Augsburg, Department of Gynecology and Obstetrics — Augsburg

Идентификаторы

NCT: NCT05899387 · 1.0

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗