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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Florence Couppey, clinical project manager
- 電話番号：+33 (0)1 46 25 31 30
- メール：f.couppey@hopital-foch.com
研究場所
-
-
-
Suresnes、フランス、92150
- Hôpital Foch
-
コンタクト：
- Florence COUPPEY, Clinical project manager
- 電話番号：+33(0)1 46 25 31 30
- メール：f.couppey@hopital-foch.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
|
|
アクティブコンパレータ：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.
|
Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CD39 Expression on Natural Killer Cells in Endometrial and Peritoneal Samples
時間枠：At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
Comparison of CD39 expression on natural killer (NK) cells in endometrial and peritoneal samples collected from women with deep endometriosis and women without endometriosis.
|
At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NK Cell Cytotoxic Function
時間枠：At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
Assessment of NK cell cytotoxic activity through degranulation markers and cytokine production in biological samples.
|
At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
|
Endometrial and NK Cell Interactions
時間枠：At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
Evaluation of interactions between endometrial cells and NK cells using tissue-based analyses.
|
At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
|
Ex Vivo Modulation of NK Cell Function
時間枠：Following sample collection, up to study completion (16 months)
|
Evaluation of the effects of cytokine stimulation on NK cell function and endometrial cell responses in laboratory assays.
|
Following sample collection, up to study completion (16 months)
|
|
Association Between Hormonal Levels and NK Cell Profile
時間枠：At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
Correlation of estrogen and progesterone levels with NK cell characteristics and immune markers.
|
At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
|
Association Between Clinical Characteristics and Immune Markers
時間枠：At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
Correlation between clinical features of endometriosis and immunological findings.
|
At sample collection during the secretory phase of the menstrual cycle (Days 16-24)
|
|
Genetic Biomarker Associations
時間枠：At sample collection and laboratory analysis up to study completion (16 months)
|
Assessment of associations between genetic markers and immunological findings.
|
At sample collection and laboratory analysis up to study completion (16 months)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Marie CARBONNEL, MD、Foch Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2024_0074
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。