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A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients (FISCO)

5. december 2019 opdateret af: Novartis

A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients

A long term observational study in sickle cell disease will enhance the understanding of the disease patterns, current transfusion practices, treatments and outcomes in sickle cell disease.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

498

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Hematology Oncology Services of Arkansas
    • California
      • Oakland, California, Forenede Stater, 94609
        • Children's Hospital Oakland (CHO)
      • Orange, California, Forenede Stater, 92668
        • Children's Hospital of Orange County Sickle Cell Disease Center
      • San Diego, California, Forenede Stater, 92123
        • Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center
    • Connecticut
      • Stamford, Connecticut, Forenede Stater, 06902
        • Hematology Oncology, P.C.
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20060
        • Howard University
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Broward Oncology Associates, P.A.
      • Miami, Florida, Forenede Stater, 33155
        • Miami Children's Hospital
      • Miami, Florida, Forenede Stater, 33179
        • Innovative Medical Research
      • Orlando, Florida, Forenede Stater, 32806
        • M.D. Anderson Cancer Center Orlando
      • Saint Petersburg, Florida, Forenede Stater, 33701
        • All Children's Hospital
      • Tampa, Florida, Forenede Stater, 33607
        • Central Tampa Hematology and Oncology Associates
      • Tampa, Florida, Forenede Stater, 33607
        • St. Joseph Children's Hospital
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago, Dept of Pediatrics
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • Abington Hematology Oncology Associates, Inc
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, Forenede Stater, 70118
        • LSU Department of Pediatrics Children's Hospital
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins University Division of Hematology
      • Clinton, Maryland, Forenede Stater, 20735
        • Oncology-Hematology Associates, P.A.
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Children's Hospital Boston - Harvard
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Comprehensive Sickle Cell Center
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49007-3731
        • West Michigan Cancer Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • University of Missouri Child Health, Division of Pediatric Hematology/Oncology
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospital
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Brooklyn, New York, Forenede Stater, 11209
        • Maimonides Medical Center
      • Brooklyn, New York, Forenede Stater, 11215
        • New York Methodist Hospital Dept of Med/Sickle Cell Program
      • Brooklyn, New York, Forenede Stater, 11238
        • Interfaith Medical Center-Comprehensive Sickle Cell Program
      • New Hyde Park, New York, Forenede Stater, 11040
        • Cohen Children's Medical Center of NY (CCMC)
      • Syracuse, New York, Forenede Stater, 13210
        • Center for Children's Cancer & Blood Disorders
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Presbyterian Hospital Pediatric Sickle Cell Program
    • Ohio
      • Akron, Ohio, Forenede Stater, 44308
        • Ohio Region VI Sickle Cell Program
      • Cincinnati, Ohio, Forenede Stater, 45229-3039
        • Cincinnati Children's Medical Center
      • Dayton, Ohio, Forenede Stater, 45404
        • The Children's Medical Center of Dayton
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of SC-Pediatric Sickle Cell Center
      • Columbia, South Carolina, Forenede Stater, 29203
        • M. Francisco Gonzalez, M.D., P.A.
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38103
        • Diggs-Kraus Sickle Cell Center
      • Nashville, Tennessee, Forenede Stater, 37208
        • Meharry Comprehensive Sickle Cell Center
      • Nashville, Tennessee, Forenede Stater, 37232-6310
        • Sickle Cell Disease and Hemoglobinopathy Clinic Children's Hospital at Vanderbilt
    • Texas
      • Houston, Texas, Forenede Stater, 77030-2399
        • Baylor College of Medicine-Texas Children's Hospital
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23601
        • Peninsula Cancer Institute

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

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

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with Sickle cell disease age 2 years and older

Beskrivelse

Inclusion Criteria:

  • Male or female patients with HbSS, HbS/beta-thalassemia and HbSC
  • Age > 2 years old.
  • Written informed consent by the patient or legal guardians, and pediatric assent where indicated.

Exclusion Criteria:

  • Patients with Sickle Cell trait (HbAS) are not eligible for the study
  • Patient or legal guardians unable or unwilling to give consent, or pediatric assent where indicated.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
No treatment
Patients aged 2 to less than 12
No treatment patients aged 12 to less than 18
Patients aged 12 to less than 18
No treatment Patients greater than 18 years
patients greater than 18 years

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Document current treatment patterns, natural history and outcomes in patients with sickle cell disease
Tidsramme: up to 5 years
up to 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Data collection
Tidsramme: up to 5 years
Collection of the following data:Current therapies used for the treatment of SCD Current transfusion practices, Difference in treatments between pediatric and adult patients, Use of chelation therapies, Frequency and types of crises including Frequency of hospitalizations, Incidence of end organ damage (caridac, renal, pulmonary,liver), Quality of life assessed by PedsQL TM Pediatric Quality of Life Inventory for patients 2- <18 years old and SF-36® Health Survey for patients 18 years old and older
up to 5 years
Measure Sickle cell crisis and hospitalizations
Tidsramme: up to 5 years
To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations
up to 5 years

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis

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

1. januar 2010

Primær færdiggørelse (Faktiske)

1. september 2014

Studieafslutning (Faktiske)

1. september 2014

Datoer for studieregistrering

Først indsendt

11. oktober 2010

Først indsendt, der opfyldte QC-kriterier

12. oktober 2010

Først opslået (Skøn)

13. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. december 2019

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CICL670AUS38

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 Suriname

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner