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Interaction Between Decidual Cells and NK Cells in Endometriosis (PAINLESS)

2026년 6월 11일 업데이트: Hopital Foch

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 프랑스
      • Suresnes, 프랑스, 92150
        • Hôpital Foch
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: Biological Sample Collection
Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.
활성 비교기: 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.
절차: Biological Sample Collection
Collection of blood samples, endometrial samples, vaginal microbiota samples, and surgical specimens when clinically indicated for immunological and biomarker analyses.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
CD39 Expression on Natural Killer Cells in Endometrial and Peritoneal Samples
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
NK Cell Cytotoxic Function
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hopital Foch

수사관

  • 수석 연구원: Marie CARBONNEL, MD, Foch hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 10월 1일

연구 완료 (추정된)

2027년 10월 1일

연구 등록 날짜

최초 제출

2026년 6월 11일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2024_0074

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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