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The Second Multicenter Hemophilia Cohort Study


N/A
13 Years
N/A
Not Enrolling
Both
Liver Decompensation, Hepatocellular Carcinoma, Non-Hodgkin Lymphoma

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Trial Information

The Second Multicenter Hemophilia Cohort Study


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Wyndham H Wilson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999901170

NCT ID:

NCT00341705

Start Date:

April 2001

Completion Date:

April 2013

Related Keywords:

  • Liver Decompensation
  • Hepatocellular Carcinoma
  • Non-Hodgkin Lymphoma
  • AIDS
  • Cancer
  • Hepatitis C Virus
  • HIV
  • Natural History
  • Hemophilia
  • Hepatitis C
  • Carcinoma
  • Hemophilia A
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Liver Failure
  • Carcinoma, Hepatocellular

Name

Location

Childrens National Medical CenterWashington, District of Columbia  
Wake Forest UniversityWinston-Salem, North Carolina  27103
Children's Hospital of Orange CountyOrange, California  92668
University of ColoradoDenver, Colorado  80217
University of OklahomaOklahoma City, Oklahoma  73190
University of MinnesotaMinneapolis, Minnesota  55455
Wayne State University Hutzel HospitalDetroit, Michigan  48201
University of California, San FranciscoSan Francisco, California  94143
University of UtahSalt Lake City, Utah  
University of ArizonaTucson, Arizona  85724
Vanderbilt UniversityNashville, Tennessee  37232-6305
University of North CarolinaChapel Hill, North Carolina  27599
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Georgetown UniversityWashington, District of Columbia  20007-2197
Emory UniversityAtlanta, Georgia  30322
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Ohio State UniversityColumbus, Ohio  43210
University of New MexicoAlbuquerque, New Mexico  87131
St. Louis UniversitySt. Louis, Missouri  63110
Mt. Sinai Medical CenterNew York, New York  10029
University of CincinnatiCincinnati, Ohio  45267-0502
Childrens Memorial Hospital, ChicagoChicago, Illinois  60614
Cornell UniversityNew York, New York  10021
Wright State UniversityDayton, Ohio  45408
University of IllinoisChicago, Illinois  60612
University of TennesseeMemphis, Tennessee  38163
Childrens Hospital of WisconsinMilwaukee, Wisconsin  53201
University of California, DavisSacramento, California  95818
Tulane UniversityNew Orleans, Louisiana  70112-2699
Milton Hershey Medical CenterHershey, Pennsylvania  17033-2390
University of Texas, HoustonHouston, Texas  77225
University of Texas, San AntonioSan Antonio, Texas  78229-3900
Christiana HospitalWilmington, Delaware  
St. Vincent's HospitalIndiannapolis, Indiana  
University of MississippiJackson, Mississippi  39216
University of BuffaloBuffalo, New York  
North Shore Long Island Jewish Health SystemLake Success, New York  11042
Childrens Hospital, CinncinatiCinncinati, Ohio  45229-3039
Palmentto Health AllianceColumbia, South Carolina  29202