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Collaboration for Down Syndrome Progress (CDP) (CDP)

28 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

1400

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Enrollment of Participants into the DS-CDP Common Protocol
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

RTI International

Samarbetspartners

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)

Utredare

  • Huvudutredare: Jessica E Hunter, PhD, RTI International

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

31 augusti 2029

Avslutad studie (Beräknad)

31 augusti 2029

Studieregistreringsdatum

Först inskickad

11 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

Ongoing, throughout the duration of the program

Kriterier för IPD Sharing Access

Through the INCLUDE Data HUB

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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