The Second Multicenter Hemophilia Cohort Study
2019年12月14日 更新者：National Cancer Institute (NCI)
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV).
The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV).
Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions.
Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another.
Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections.
Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.
研究概览
详细说明
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV).
The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV).
Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions.
Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another.
Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections.
Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.
研究类型
观察性的
注册 (实际的)
2565
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
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New Brunswick、加拿大
- South East Health Care Corporation
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Sao Paulo、巴西
- Hospital Brigadeiro
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Sao Paulo、巴西
- University of Sao Paulo
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Athens、希腊
- Laikon General Hospital of Athens
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Bonn、德国
- University of Bonn
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Florence、意大利
- University of Florence
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Milan、意大利
- University de Milano
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Lyons、法国
- Hospices Civils de Lyon
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Stockholm、瑞典
- Karolinska Institute St. Gorans Hospital
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Arizona
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Tucson、Arizona、美国、85724
- University of Arizona
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California
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Davis、California、美国、95616
- University of California, Davis
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Orange、California、美国、92613
- Children's Hospital of Orange County
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San Francisco、California、美国、94143
- University of California, San Francisco
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Colorado
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Denver、Colorado、美国、80220-3706
- University Of Colorado
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Delaware
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Wilmington、Delaware、美国
- Christiana Hospital
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District of Columbia
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Washington、District of Columbia、美国
- Childrens National Medical Center
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Washington、District of Columbia、美国、20007-2197
- Georgetown University
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Georgia
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Atlanta、Georgia、美国、30322-1102
- Emory University
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Illinois
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Chicago、Illinois、美国、60612
- University of Illinois
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Chicago、Illinois、美国、60614-3394
- Childrens Memorial Hospital, Chicago
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Indiana
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Indianapolis、Indiana、美国
- St. Vincent's Hospital
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Louisiana
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New Orleans、Louisiana、美国、70112-2699
- Tulane University
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Michigan
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Detroit、Michigan、美国、48201
- Wayne State University Hutzel Hospital
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Minnesota
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Minneapolis、Minnesota、美国、55415
- University of Minnesota
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Mississippi
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Jackson、Mississippi、美国、39216
- University of Mississippi
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Missouri
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Saint Louis、Missouri、美国、63104
- St. Louis University
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New Mexico
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Albuquerque、New Mexico、美国、87131
- University of New Mexico
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New York
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Buffalo、New York、美国
- University of Buffalo
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Lake Success、New York、美国、11042
- North Shore Long Island Jewish Health System
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New York、New York、美国、10021-4872
- Cornell University
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New York、New York、美国、10029-0574
- Mt. Sinai Medical Center
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North Carolina
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Chapel Hill、North Carolina、美国、27599-7030
- University of North Carolina
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Winston-Salem、North Carolina、美国、27103
- Wake Forest University
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Ohio
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Cincinnati、Ohio、美国、45267
- University of Cincinnati
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Cincinnati、Ohio、美国、45229-3039
- Childrens Hospital, Cinncinati
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Columbus、Ohio、美国、43210-1240
- Ohio State University
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Dayton、Ohio、美国、45435
- Wright State University
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Oklahoma
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Oklahoma City、Oklahoma、美国
- University of Oklahoma
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Milton Hershey Medical Center
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Philadelphia、Pennsylvania、美国、19104-6056
- University of Pennsylvania
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Philadelphia、Pennsylvania、美国、19107-6541
- Thomas Jefferson University
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South Carolina
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Columbia、South Carolina、美国、29202
- Palmentto Health Alliance
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Tennessee
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Memphis、Tennessee、美国、38103
- University of Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt University
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Texas
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Houston、Texas、美国、77030
- University of Texas, Houston
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San Antonio、Texas、美国
- University of Texas, San Antonio
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Utah
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Salt Lake City、Utah、美国、84112
- University of Utah
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Wisconsin
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Milwaukee、Wisconsin、美国
- Childrens Hospital of Wisconsin
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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
13年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
- INCLUSION CRITERIA:
Must be registered patient with an inherited coagulation disorder at a participating MHCS-II center. Disorders include hemophilia A or B (congenital factor VIII or IX deficiency), deficiencies in other factors such as V or XI, and vonWillebrand's disease. (Unless noted otherwise, all of the disorders will collectively be referred to as hemophilia .) All such hemophilia and vonWillebrand s disease patients are to be recruited as study participants.
Since January 1, 1993, must have had at least one positive result on a licensed assay for HCV antibodies, HIV antibodies, or HIV RNA.
Must be at least 13 years of age at enrollment.
Must provide signed informed consent or, for minors, signed assent plus signed informed consent from the parent or guardian.
EXCLUSION CRITERIA:
Is not a patient with an inherited coagulation disorder.
Does not have a positive test for HCV antibodies, HIV antibodies, or HIV RNA on a licensed assay performed since January 1, 1993.
Is less than 13 years of age.
Lacks informed consent/assent.
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？
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。
调查人员
- 首席研究员：James J Goedert, M.D.、National Cancer Institute (NCI)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17.
- Kroner BL, Rosenberg PS, Aledort LM, Alvord WG, Goedert JJ. HIV-1 infection incidence among persons with hemophilia in the United States and western Europe, 1978-1990. Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1994 Mar;7(3):279-86.
- Eyster ME, Diamondstone LS, Lien JM, Ehmann WC, Quan S, Goedert JJ. Natural history of hepatitis C virus infection in multitransfused hemophiliacs: effect of coinfection with human immunodeficiency virus. The Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1993 Jun;6(6):602-10.
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
2001年4月27日
研究完成
2013年4月2日
研究注册日期
首次提交
2006年6月19日
首先提交符合 QC 标准的
2006年6月19日
首次发布 (估计)
2006年6月21日
研究记录更新
最后更新发布 (实际的)
2019年12月17日
上次提交的符合 QC 标准的更新
2019年12月14日
最后验证
2013年4月2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.