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The Second Multicenter Hemophilia Cohort Study

14. december 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2565

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • Sao Paulo, Brasilien
        • Hospital Brigadeiro
      • Sao Paulo, Brasilien
        • University of Sao Paulo
  • Canada
      • New Brunswick, Canada
        • South East Health Care Corporation
  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85724
        • University of Arizona
    • California
      • Davis, California, Forenede Stater, 95616
        • University of California, Davis
      • Orange, California, Forenede Stater, 92613
        • Children's Hospital of Orange County
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco
    • Colorado
      • Denver, Colorado, Forenede Stater, 80220-3706
        • University of Colorado
    • Delaware
      • Wilmington, Delaware, Forenede Stater
        • Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater
        • Childrens National Medical Center
      • Washington, District of Columbia, Forenede Stater, 20007-2197
        • Georgetown University
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322-1102
        • Emory University
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois
      • Chicago, Illinois, Forenede Stater, 60614-3394
        • Childrens Memorial Hospital, Chicago
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
        • St. Vincent's Hospital
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112-2699
        • Tulane University
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University Hutzel Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • University of Minnesota
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63104
        • St. Louis University
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131
        • University of New Mexico
    • New York
      • Buffalo, New York, Forenede Stater
        • University of Buffalo
      • Lake Success, New York, Forenede Stater, 11042
        • North Shore Long Island Jewish Health System
      • New York, New York, Forenede Stater, 10021-4872
        • Cornell University
      • New York, New York, Forenede Stater, 10029-0574
        • Mt. Sinai Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7030
        • University of North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Wake Forest University
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, Forenede Stater, 45229-3039
        • Childrens Hospital, Cinncinati
      • Columbus, Ohio, Forenede Stater, 43210-1240
        • Ohio State University
      • Dayton, Ohio, Forenede Stater, 45435
        • Wright State University
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • University of Oklahoma
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Milton Hershey Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-6056
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107-6541
        • Thomas Jefferson University
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29202
        • Palmentto Health Alliance
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38103
        • University of Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas, Houston
      • San Antonio, Texas, Forenede Stater
        • University of Texas, San Antonio
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • University of Utah
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater
        • Childrens Hospital of Wisconsin
  • Frankrig
      • Lyons, Frankrig
        • Hospices Civils de Lyon
  • Grækenland
      • Athens, Grækenland
        • Laikon General Hospital of Athens
  • Italien
      • Florence, Italien
        • University of Florence
      • Milan, Italien
        • University de Milano
  • Sverige
      • Stockholm, Sverige
        • Karolinska Institute St. Gorans Hospital
  • Tyskland
      • Bonn, Tyskland
        • University of Bonn

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Samarbejdspartnere

Multicenter Hemophilia Cohort Study

Efterforskere

  • Ledende efterforsker: James J Goedert, M.D., National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

27. april 2001

Studieafslutning

2. april 2013

Datoer for studieregistrering

Først indsendt

19. juni 2006

Først indsendt, der opfyldte QC-kriterier

19. juni 2006

Først opslået (Skøn)

21. juni 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2019

Sidst verificeret

2. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 999901170
  • 01-C-N170

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Korea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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