Interaction Between Decidual Cells and NK Cells in Endometriosis (PAINLESS)
Interaction Between Decidual Cells and Natural Killer Cells in Endometriosis: A Prospective Pilot Case-Control Study
Endometriosis is a chronic gynecological disease characterized by the presence of endometrial-like tissue outside the uterus and is frequently associated with pelvic pain and infertility. Increasing evidence suggests that immune dysfunction may contribute to the development and persistence of the disease.
The purpose of this prospective case-control study is to compare immune cell characteristics in women with deep endometriosis and women without endometriosis during the secretory phase of the menstrual cycle. Participants will undergo collection of clinical data, blood samples, endometrial samples, and vaginal microbiota samples. For participants undergoing clinically indicated pelvic surgery, additional biological samples may be collected during the procedure. The study aims to improve understanding of the immune mechanisms involved in endometriosis and to identify potential biomarkers associated with the disease.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Endometriosis affects approximately 10-15% of women of reproductive age and represents a major public health concern. Despite its high prevalence, the pathophysiological mechanisms underlying the disease remain incompletely understood. Increasing evidence suggests that alterations in the immune environment of the endometrium may contribute to the establishment and progression of endometriosis. In particular, uterine immune cells may play a role in regulating local inflammation and tissue homeostasis. Characterizing these immune mechanisms may improve understanding of disease development and identify potential biomarkers associated with endometriosis.
PAINLESS is a prospective, single-center, pilot case-control study conducted at Foch Hospital (Suresnes, France). The study will enroll 50 adult women, including 25 participants with confirmed deep endometriosis and 25 control participants without endometriosis.
Biological samples will be collected during the secretory phase of the menstrual cycle (days 16-24). Depending on clinical management, study procedures may include:
- Collection of demographic and clinical data
- Assessment of symptoms and quality of life
- Blood sampling
- Endometrial sampling
- Vaginal microbiota sampling
- Collection of additional biological specimens during clinically indicated pelvic surgery.
Biological samples will be analyzed to characterize immune cell populations, evaluate soluble immune mediators, investigate associations with hormonal and clinical parameters, and explore biological mechanisms involved in endometriosis.The primary objective is to compare the expression of immune-related markers in endometrial and peritoneal samples obtained from women with endometriosis and controls. Secondary objectives include characterization of immune cell phenotypes and functions, evaluation of immune-related soluble factors, investigation of interactions between immune and endometrial cells, assessment of correlations with hormonal and clinical data, exploratory genetic analyses, and creation of a vaginal microbiota biobank. Results from this pilot study are expected to provide preliminary data for future research aimed at improving the understanding, diagnosis, and management of endometriosis.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Florence Couppey, clinical project manager
- Номер телефона: +33 (0)1 46 25 31 30
- Электронная почта: f.couppey@hopital-foch.com
Места учебы
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Suresnes, Франция, 92150
- Hôpital Foch
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Контакт:
- Florence COUPPEY, Clinical project manager
- Номер телефона: +33(0)1 46 25 31 30
- Электронная почта: f.couppey@hopital-foch.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Endometriosis Group
- Female participant aged 18 years or older.
- Confirmed diagnosis of deep endometriosis by imaging or surgery.
- Pelvic pain and/or severe dysmenorrhea (Visual Analog Scale > 4).
- Premenopausal.
- No contraceptive or hormonal treatment during the study menstrual cycle.
- Affiliated with a health insurance system.
- Able and willing to provide written informed consent.
- Control Group
- Female participant aged 18 years or older.
- No diagnosis of endometriosis.
- Premenopausal.
- No contraceptive or hormonal treatment during the study menstrual cycle.
- No chronic pelvic pain or severe dysmenorrhea (Visual Analog Scale < 4).
- Affiliated with a health insurance system.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Current infection.
- Active cancer.
- Active autoimmune disease.
- Concomitant hormonal treatment.
- Pregnancy.
- Participant under guardianship or legal protection.
- Participant deprived of liberty.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Endometriosis Group
Adult women with confirmed deep endometriosis undergoing collection of clinical data and biological samples, including blood, endometrial tissue, vaginal microbiota samples, and, when clinically indicated, additional samples collected during pelvic surgery.
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Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
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Активный компаратор: Control Group
Adult women without endometriosis undergoing collection of clinical data and biological samples, including blood, endometrial tissue, vaginal microbiota samples, and, when clinically indicated, additional samples collected during pelvic surgery.
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Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
CD39 Expression on Natural Killer Cells in Endometrial and Peritoneal Samples
Временное ограничение: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Comparison of CD39 expression on natural killer (NK) cells in endometrial and peritoneal samples collected from women with deep endometriosis and women without endometriosis.
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At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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NK Cell Cytotoxic Function
Временное ограничение: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Assessment of NK cell cytotoxic activity through degranulation markers and cytokine production in biological samples.
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At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Endometrial and NK Cell Interactions
Временное ограничение: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Evaluation of interactions between endometrial cells and NK cells using tissue-based analyses.
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At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Ex Vivo Modulation of NK Cell Function
Временное ограничение: Following sample collection, up to study completion (16 months)
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Evaluation of the effects of cytokine stimulation on NK cell function and endometrial cell responses in laboratory assays.
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Following sample collection, up to study completion (16 months)
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Association Between Hormonal Levels and NK Cell Profile
Временное ограничение: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Correlation of estrogen and progesterone levels with NK cell characteristics and immune markers.
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At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Association Between Clinical Characteristics and Immune Markers
Временное ограничение: At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Correlation between clinical features of endometriosis and immunological findings.
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At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
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Genetic Biomarker Associations
Временное ограничение: At sample collection and laboratory analysis up to study completion (16 months)
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Assessment of associations between genetic markers and immunological findings.
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At sample collection and laboratory analysis up to study completion (16 months)
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Marie CARBONNEL, MD, Foch Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Генитальные заболевания
- Боль
- Неврологические проявления
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Заболевания половых органов, Женский
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Эндометриоз
- Боль в области таза
Другие идентификационные номера исследования
- 2024_0074
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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