Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Establishing a Database of People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Data Project [C-Data]) (C-Data)

11. juli 2016 opdateret af: National Heart, Lung, and Blood Institute (NHLBI)

Comprehensive Sickle Cell Centers Collaborative Data Project (C-Data)

Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to gather medical information from children and adults with SCD and establish a database so that researchers can contact people to participate in future SCD research studies.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." The Comprehensive Sickle Cell Centers (CSCC) is a network of 10 centers that conduct research to improve health care and treatment options for people with SCD. This study, the Collaborative Data Project (C-Data), will establish a comprehensive database of children and adults receiving medical care at participating CSCC research centers who are potentially eligible for inclusion in SCD clinical trials. The main purposes of this study are the following: 1) to gather medical information about a large number of people with SCD over a long period of time; 2) to identify potential participants for future SCD clinical trials; 3) to collect information about how SCD affects quality of life; and 4) to evaluate the relationship between SCD patients' characteristics and medical events.

In this study, research staff will review participants' medical records twice a year for at least 5 years. Information will be collected regarding participants' medical history, physical exams, blood tests, and demographics. Once a year, participants will take part in a short interview about their health and lifestyle. Participants will also complete quality-of-life and patient satisfaction questionnaires during the first year of the study and may complete additional questionnaires in the future. During an interview, participants will be asked general questions about their experience with SCD and more specific questions on headaches and any possible relation they may have to SCD pain. Participants may also be asked to provide a blood sample at some point during the study. CSCC researchers will analyze the information in the database and may contact participants in the future to see if they are interested in enrolling in SCD clinical trials.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3640

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Oakland, California, Forenede Stater, 94609
        • Children's Hospital of Oakland
      • San Francisco, California, Forenede Stater, 94134
        • University of California, San Francisco
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Kosair Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Medical Center
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham & Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02115
        • Children's Hospital of Boston
    • New York
      • Bronx, New York, Forenede Stater, 10463
        • Montefiore Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina-Chapel Hill
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19134
        • St. Christopher's Hospital for Children
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105
        • Saint Jude Children's Hospital
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Children's Medical Center of Dallas
      • Dallas, Texas, Forenede Stater, 75235
        • University of Texas Southwestern and Parkland
      • Galveston, Texas, Forenede Stater, 77555
        • University of Texas at Galveston

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All adult and pediatric patients who have been seen within the last 24 months in the hospital or clinical setting, and are expected to return episodically or regularly for care at one of the CSCCs, are eligible for inclusion in the C-Data project.

Beskrivelse

Inclusion Criteria:

  • Diagnosis of SCD
  • Evaluated within the 24 months prior to study entry in the hospital or clinical setting
  • Expected to return episodically or regularly for care at one of the CSCCs

Exclusion Criteria:

  • Deceased CSCC patient
  • Inactive CSCC patient

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

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

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

  • Ledende efterforsker: Susi Lieff, PhD, Statistics and Data Management Center (SDMC) (RhoFed)

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. marts 2005

Primær færdiggørelse (Faktiske)

1. september 2008

Studieafslutning (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

12. september 2007

Først indsendt, der opfyldte QC-kriterier

12. september 2007

Først opslået (Skøn)

14. september 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2016

Sidst verificeret

1. november 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1401
  • U54HL070587-05 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Anæmi, seglcelle

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Australia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner