Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Collaboration for Down Syndrome Progress (CDP) (CDP)

28 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

1400

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Locaties

  • Verenigde Staten
    • California
      • Orange, California, Verenigde Staten, 92868
        • Nog niet aan het werven
        • University of California Irvine
        • Contact:
          • Christy L Hom, PhD
          • Telefoonnummer: 714-456-5902
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • Nog niet aan het werven
        • University of Colorado Anschutz Medical Campus
        • Contact:
          • Joaquin Espinosa, PhD
          • Telefoonnummer: 303-724-7389
    • Florida
      • Miami, Florida, Verenigde Staten, 33136
        • Nog niet aan het werven
        • University of Miami
        • Contact:
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • Nog niet aan het werven
        • Kansas University Medical Center
        • Contact:
          • Lauren T Ptomey, PhD, RD, LD
          • Telefoonnummer: 913-588-5000
          • E-mail: lptomey@kumc.edu
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21287
        • Nog niet aan het werven
        • John Hopkins University
        • Contact:
          • Sheela N Magge, MD, MSCE
          • Telefoonnummer: 443-997-5437
          • E-mail: smagge3@jhmi.edu
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55455
        • Nog niet aan het werven
        • University of Minnesota
        • Contact:
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63108
        • Nog niet aan het werven
        • Washington University in St. Louis
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • Nog niet aan het werven
        • University of North Carolina at Chapel Hill
        • Contact:
          • Heather Hazlett, PhD
          • Telefoonnummer: 919-966-4099
          • E-mail: cody@ad.unc.edu
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Nog niet aan het werven
        • The Children's Hospital of Philadelphia
        • Contact:
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15203
        • Nog niet aan het werven
        • University of Pittsburgh
        • Contact:
          • Bejamin L Handen, PhD
          • Telefoonnummer: 412-235-5445 Expertise
          • E-mail: handenbl@upmc.edu
    • Tennessee
      • Memphis, Tennessee, Verenigde Staten, 38105
        • Nog niet aan het werven
        • St. Jude Children's Research Hospital
        • Contact:
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • Nog niet aan het werven
        • Texas Children's Hosptial/Baylor College of Medicine
        • Contact:
          • Mirjana Maletic-Savatic, MD, PhD
          • Telefoonnummer: (832) 822-1700
          • E-mail: maletics@bcm.edu
      • San Antonio, Texas, Verenigde Staten, 78207
        • Nog niet aan het werven
        • University of Texas Health Science Center at San Antionio
        • Contact:
    • Washington
      • Seattle, Washington, Verenigde Staten, 98195
        • Nog niet aan het werven
        • University of Washington
        • Contact:
          • Stephen Dager, MD
          • Telefoonnummer: 877-408-UWAC
          • E-mail: srd@uw.edu
    • Wisconsin
      • Madison, Wisconsin, Verenigde Staten, 53705
        • Werving
        • University of Wisconsin-Madison
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Enrollment of Participants into the DS-CDP Common Protocol
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

RTI International

Medewerkers

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)

Onderzoekers

  • Hoofdonderzoeker: Jessica E Hunter, PhD, RTI International

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2026

Primaire voltooiing (Geschat)

31 augustus 2029

Studie voltooiing (Geschat)

31 augustus 2029

Studieregistratiedata

Eerst ingediend

11 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DS-4C (36648)
  • 1U54HL178351 (Subsidie/contract van de Amerikaanse NIH)
  • 1U01HD116485 (Subsidie/contract van de Amerikaanse NIH)
  • 1U01HD116470 (Subsidie/contract van de Amerikaanse NIH)
  • 1U01HD116469 (Subsidie/contract van de Amerikaanse NIH)
  • 1U01HD116477 (Subsidie/contract van de Amerikaanse NIH)
  • 1U01HD116463 (Subsidie/contract van de Amerikaanse NIH)
  • 1U24AG092191 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

Ongoing, throughout the duration of the program

IPD-toegangscriteria voor delen

Through the INCLUDE Data HUB

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren