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Collaboration for Down Syndrome Progress (CDP) (CDP)

28. mai 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

1400

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

RTI International

Samarbeidspartnere

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)

Etterforskere

  • Hovedetterforsker: Jessica E Hunter, PhD, RTI International

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

31. august 2029

Studiet fullført (Antatt)

31. august 2029

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

Through the INCLUDE Data HUB

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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