Non Hodgkin Lymphoma Clinical Trial

The Second Multicenter Hemophilia Cohort Study

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

2565

Study ID:

NCT00341705

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 32 Locations for this study

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University of Arizona
Tucson Arizona, 85724, United States
University of California, Davis
Davis California, 95616, United States
Children's Hospital of Orange County
Orange California, 92613, United States
University of California, San Francisco
San Francisco California, 94143, United States
University of Colorado
Denver Colorado, 80220, United States
Christiana Hospital
Wilmington Delaware, , United States
Georgetown University
Washington District of Columbia, 20007, United States
Childrens National Medical Center
Washington District of Columbia, , United States
Emory University
Atlanta Georgia, 30322, United States
University of Illinois
Chicago Illinois, 60612, United States
Childrens Memorial Hospital, Chicago
Chicago Illinois, 60614, United States
St. Vincent's Hospital
Indianapolis Indiana, , United States
Tulane University
New Orleans Louisiana, 70112, United States
Wayne State University Hutzel Hospital
Detroit Michigan, 48201, United States
University of Minnesota
Minneapolis Minnesota, 55415, United States
University of Mississippi
Jackson Mississippi, 39216, United States
St. Louis University
Saint Louis Missouri, 63104, United States
University of New Mexico
Albuquerque New Mexico, 87131, United States
University of Buffalo
Buffalo New York, , United States
North Shore Long Island Jewish Health System
Lake Success New York, 11042, United States
Cornell University
New York New York, 10021, United States
Mt. Sinai Medical Center
New York New York, 10029, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Wake Forest University
Winston-Salem North Carolina, 27103, United States
Childrens Hospital, Cinncinati
Cincinnati Ohio, 45229, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Ohio State University
Columbus Ohio, 43210, United States
Wright State University
Dayton Ohio, 45435, United States
University of Oklahoma
Oklahoma City Oklahoma, , United States
Milton Hershey Medical Center
Hershey Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Palmentto Health Alliance
Columbia South Carolina, 29202, United States
University of Tennessee
Memphis Tennessee, 38103, United States
Vanderbilt University
Nashville Tennessee, 37232, United States
University of Texas, Houston
Houston Texas, 77030, United States
University of Texas, San Antonio
San Antonio Texas, , United States
University of Utah
Salt Lake City Utah, 84112, United States
Childrens Hospital of Wisconsin
Milwaukee Wisconsin, , United States
Hospital Brigadeiro
Sao Paulo , , Brazil
University of Sao Paulo
Sao Paulo , , Brazil
South East Health Care Corporation
New Brunswick , , Canada
Hospices Civils de Lyon
Lyons , , France
University of Bonn
Bonn , , Germany
Laikon General Hospital of Athens
Athens , , Greece
University of Florence
Florence , , Italy
University de Milano
Milan , , Italy
Karolinska Institute St. Gorans Hospital
Stockholm , , Sweden

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

2565

Study ID:

NCT00341705

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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