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Collaboration for Down Syndrome Progress (CDP) (CDP)

28. maj 2026 opdateret af: Jessica Ezzell Hunter, RTI International

The INCLUDE (INvestigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome) Project's Collaboration for Down Syndrome Progress (CDP) Program

The Collaboration for Down Syndrome Progress (CDP) is a long-term study that follows people with Down syndrome of all ages. The goal is to better understand their health, development, and everyday experiences over time. Participants and their caregivers will answer questions, share medical information, and may give samples like blood or saliva. Some participants may also take part in optional activities such as sleep studies, movement tracking, or brain imaging. By collecting the same types of information at many sites, the CDP will help researchers learn why certain health conditions are more common in people with Down syndrome and how to improve care and quality of life.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

The Collaboration for Down Syndrome Progress (CDP) is a multisite, prospective longitudinal cohort designed to systematically characterize health, neurodevelopmental, neurobehavioral, and biological trajectories in individuals with Down syndrome across the lifespan. The CDP establishes a harmonized data collection framework implemented across U.S. and international clinical research sites to generate a large, integrated dataset suitable for cross-sectional and longitudinal analyses.

Participants undergo standardized assessments that include medical history, neurobehavioral evaluations, physical examinations, and review of electronic health records. Biospecimens-including blood, saliva, and tongue swabs-are collected to support genomic, transcriptomic, proteomic, metabolomic, and microbiome analyses. These samples are processed and stored within the Down Syndrome Biorepository for current and future research use.

The CDP also incorporates several optional subsample studies that provide deeper phenotyping in key domains relevant to co-occurring conditions in Down syndrome. These include home sleep apnea testing, wearable activity monitoring, neuroimaging using MRI, and metabolic and endocrine laboratory profiling. Each subsample follows additional standardized procedures to ensure comparability across sites.

All data generated through the CDP are curated and transferred to the NIH INCLUDE Data Hub, where they are made available in de identified form to qualified researchers. The resulting dataset is intended to advance understanding of co-occurring conditions, identify risk and resilience factors, and inform the development of evidence-based clinical practices and future therapeutic interventions for individuals with Down syndrome.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1400

Kontakter og lokationer

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

Studiekontakt

  • Navn: Jessica E Hunter, PhD
  • Telefonnummer: 919 541 6000
  • E-mail: jehunter@rti.org

Studiesteder

  • Forenede Stater
    • California
      • Orange, California, Forenede Stater, 92868
        • Ikke rekrutterer endnu
        • University of California Irvine
        • Kontakt:
          • Christy L Hom, PhD
          • Telefonnummer: 714-456-5902
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Ikke rekrutterer endnu
        • University of Colorado Anschutz Medical Campus
        • Kontakt:
          • Joaquin Espinosa, PhD
          • Telefonnummer: 303-724-7389
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Ikke rekrutterer endnu
        • University of Miami
        • Kontakt:
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Ikke rekrutterer endnu
        • Kansas University Medical Center
        • Kontakt:
          • Lauren T Ptomey, PhD, RD, LD
          • Telefonnummer: 913-588-5000
          • E-mail: lptomey@kumc.edu
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Ikke rekrutterer endnu
        • John Hopkins University
        • Kontakt:
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Ikke rekrutterer endnu
        • University of Minnesota
        • Kontakt:
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63108
        • Ikke rekrutterer endnu
        • Washington University in St. Louis
        • Kontakt:
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Ikke rekrutterer endnu
        • University of North Carolina at Chapel Hill
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Ikke rekrutterer endnu
        • The Children's Hospital of Philadelphia
        • Kontakt:
      • Pittsburgh, Pennsylvania, Forenede Stater, 15203
        • Ikke rekrutterer endnu
        • University of Pittsburgh
        • Kontakt:
          • Bejamin L Handen, PhD
          • Telefonnummer: 412-235-5445 Expertise
          • E-mail: handenbl@upmc.edu
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38105
        • Ikke rekrutterer endnu
        • St. Jude Children's Research Hospital
        • Kontakt:
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Ikke rekrutterer endnu
        • Texas Children's Hosptial/Baylor College of Medicine
        • Kontakt:
          • Mirjana Maletic-Savatic, MD, PhD
          • Telefonnummer: (832) 822-1700
          • E-mail: maletics@bcm.edu
      • San Antonio, Texas, Forenede Stater, 78207
        • Ikke rekrutterer endnu
        • University of Texas Health Science Center at San Antionio
        • Kontakt:
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • Ikke rekrutterer endnu
        • University of Washington
        • Kontakt:
          • Stephen Dager, MD
          • Telefonnummer: 877-408-UWAC
          • E-mail: srd@uw.edu
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53705
        • Rekruttering
        • University of Wisconsin-Madison
        • Kontakt:

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

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The CDP is enrolling individuals with Down syndrome of all ages and a small number of control participants without Down syndrome from a wide range of backgrounds, including variation in age, geographic location, and functional abilities. Included in enrollment for individuals with Down syndrome is a Support Person to assist in completion of some CDP activities.

Beskrivelse

Inclusion Criteria:

  • Individual with Down syndrome

To be considered potentially eligible for this CDP, a participant must meet the following criteria:

  • Diagnosis of Down syndrome (with the exception of control participants for the Subsample study on Imaging). We will be enrolling participants with all types of Down syndrome including standard Trisomy 21, mosaic Down syndrome, and translocations.
  • Primary language is English, Spanish, or Portuguese.

Support Person

  • Able to attend in-person or remote visits.
  • Able to provide accurate information about the study participant's clinical outcomes and family history.
  • Primary language is English, Spanish, or Portuguese.

Biological parent(s) biospecimen collection

  • Biological parent of the enrolled participant.
  • Willing to provide a biological sample.
  • Primary language is English, Spanish, or Portuguese. Imaging subsample study controls
  • A subset of controls will be enrolled to match a cohort of individuals who take part in the CDP Subsample Study on imaging. Healthy control infants must be born at greater than 36 weeks gestational age and must have at least one older sibling. The sibling criterion allows comparability for potential analyses combining control data from DS-CDP with analogous control data previously collected by IBIS for other neurodevelopmental studies.

Exclusion Criteria:

  • A participant will also be excluded if a healthcare professional determines that CDP involvement poses a risk of mental and physical harm to the participant.

Imaging subsample study exclusion criteria for individuals with Down syndrome and controls:

  • Known genetic conditions or syndromes with effects on neurobehavioral development (except for Down syndrome) such as Fragile X syndrome, Williams syndrome, or Prader-Willi syndrome. We may also exclude other syndromes such as Marfan's syndrome or Turner syndrome because of overall significant multisystem effects.
  • Birth weight < 2,000 grams or gestational age < 34 weeks (infants with Down syndrome infants) or <37 weeks (control subjects)
  • Significant perinatal adversity, in utero neurotoxin exposure or maternal gestational diabetes requiring medication management

  • Significant medical conditions (unrelated to Down syndrome) affecting growth, development, cognition or sensory impairments. We will conduct a review of the medical history to identify major medical conditions that might be a reason for exclusion.

    • Neurological event like a stroke
    • Congenital infection associated with altered development (e.g., congenital rubella)
    • Significant infection affecting the brain after birth, like meningitis

  • In infants with Down syndrome, severe medical issues which may exert significant developmental effects beyond Down syndrome such as:

    • Cyanotic cardiac abnormalities (e.g., Tetralogy of Fallot) that affect overall oxygen levels
    • Frailty because of recovery from significant surgery or extended hospital stays
  • Contraindication for MRI
  • English not predominant home language
  • Family history of a first-degree relative with psychosis or bipolar disorder (controls only)
  • To be consistent with prior imaging studies from the infant brain imaging study, healthy controls will additionally be excluded for a family history of a first- or second-degree relative with ASD to also allow them to serve as a comparison group for elevated familial liability for ASD.

Sleep subsample study exclusion criteria:

  • Participants under the age of 12 who are currently being treated for obstructive sleep apnea using a positive airway pressure (PAP) device.
  • For the WatchPAT device, participants must weigh more than 65 pounds. They cannot have a permanent pacemaker or sustained non-sinus cardiac arrhythmias.

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
CDP Down Syndrome Cohort
Individuals with Down syndrome enrolled in the CDP Common Protocol. Participants complete standardized questionnaires, neurobehavioral assessments, medical examinations, and biospecimen collection. Medical records are reviewed, and data are harmonized across all sites. A subset of CDP participants may participate in sleep studies, activity monitoring, imaging and metabolic/endocrine blood collection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Enrollment of Participants into the DS-CDP Common Protocol
Tidsramme: 4 years
The primary aim of the DS-CDP is enrollment of up to 1,400 participants with Down syndrome across the lifespan into the Common Protocol to support future cross-sectional and longitudinal research
4 years

Samarbejdspartnere og efterforskere

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

Sponsor

RTI International

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Jessica E Hunter, PhD, RTI International

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.

Hjælpsomme links

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 (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

31. august 2029

Studieafslutning (Anslået)

31. august 2029

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DS-4C (36648)
  • 1U54HL178351 (U.S. NIH-bevilling/kontrakt)
  • 1U01HD116485 (U.S. NIH-bevilling/kontrakt)
  • 1U01HD116470 (U.S. NIH-bevilling/kontrakt)
  • 1U01HD116469 (U.S. NIH-bevilling/kontrakt)
  • 1U01HD116477 (U.S. NIH-bevilling/kontrakt)
  • 1U01HD116463 (U.S. NIH-bevilling/kontrakt)
  • 1U24AG092191 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

IPD will be available to other researchers through the INCLUDE Data Hub.

IPD-delingstidsramme

Ongoing, throughout the duration of the program

IPD-delingsadgangskriterier

Through the INCLUDE Data HUB

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Downs syndrom

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

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Sponsor / samarbejdspartnere

Placeringer

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