Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
2020年1月3日 更新者：Yale University
This study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery.
The investigators plan to enroll approximately 500 women to validate and optimize the use of genomic classifiers alone or in combination with serum markers (such as cytokines) as a non-surgical marker of disease.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
114
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Connecticut
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New Haven、Connecticut、美国、06520
- Yale University
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Georgia
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Augusta、Georgia、美国、30912
- Augusta University
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Michigan
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Southfield、Michigan、美国、48034
- Wayne State University
-
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Pennsylvania State University
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 44年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Females aged 18-44 who are scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).
Indications for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
描述
Exclusion Criteria:
• Currently pregnant
- Current or past diagnosis of any malignancy (with the exception of non-melanoma skin cancer)
- Known to be HIV-positive
- Unable to give informed consent
- Unwillingness to have samples banked in Repository for future use
- Clinical evidence of active cervical infection
- Lupron (or other GRH agonist) therapy within the last 2 months (or Depo-Lupron within the last 4 months)
Current use of estrogen or progestin (oral, transdermal, intrauterine or ring).
o Current use is defined as use in the index menstrual cycle (since the onset of the last menstrual period).
- Use of depo estrogen or progestin in last 3 months
- Current use of aromatase inhibitor
Inclusion Criteria:
- Women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).
Indication for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Collection of up to 3 2cm samples of Endometrial Tissue
大体时间：2 collection timepoints: baseline and up to 18 weeks following surgery.
|
Up to 3 2cm samples will be collected per collection.
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2 collection timepoints: baseline and up to 18 weeks following surgery.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Collection of Serum 1 will be 2 10ml serum tubes of serum
大体时间：3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
|
2 10ml serum tubes will be drawn at each collection, up to 10 1.0ml aliquots per collection.
|
3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
|
|
Collection of Serum 2 will be 2 7 ml serum tubes of serum
大体时间：3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
|
2 7ml serum tubes drawn at each collection, up to 10 1.0ml aliquots of serum plus 1 15ml conical tube with the 2 blood clots per collection.
|
3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Collection of Plasma in 1 4ml EDTA tube
大体时间：3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
|
1 4ml EDTA tube will be drawn at each collection, up to 3 1.0ml aliquots per collection.
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3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
|
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Collection of Whole Blood in 2 4ml EDTA tubes
大体时间：3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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2 4ml EDTA tubes will be drawn at each collection, up to 2 4.5ml aliquots as well as 1 FTA blood spot collection card per collection.
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3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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Collection of Urine will be one complete sample as produced by the subject
大体时间：3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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1 urine sample will be collected each time, up to 6 15ml aliquots and 5 1.5ml aliquots per collection will be taken.
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3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅：Nanette Santoro, MD、University of Colorado, Denver
- 研究主任：Esther Eisenberg, MD MPH、Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 首席研究员：Kurt Barnhart, MD MSCE、University of Pennsylvania
- 首席研究员：Michael Diamond, MD、Augusta University
- 首席研究员：Richard Legro, MD、Milton S. Hershey Medical Center
- 首席研究员：Marcelle Cedars, MD、University of California, San Francisco
- 首席研究员：Anne Steiner, MD MPH、University of North Carolina
- 首席研究员：Karl Hansen, MD PhD、University of Oklahoma
- 首席研究员：Christos Coutifaris, MD PhD、University of Pennsylvania
- 首席研究员：Heping Zhang, PhD、Yale University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月8日
初级完成 (实际的)
2019年8月1日
研究完成 (实际的)
2019年12月1日
研究注册日期
首次提交
2015年11月13日
首先提交符合 QC 标准的
2017年5月18日
首次发布 (实际的)
2017年5月22日
研究记录更新
最后更新发布 (实际的)
2020年1月6日
上次提交的符合 QC 标准的更新
2020年1月3日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.