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Collaboration for Down Syndrome Progress (CDP) (CDP)

28 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

1400

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jessica E Hunter, PhD
  • Número de teléfono: 919 541 6000
  • Correo electrónico: jehunter@rti.org

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Orange, California, Estados Unidos, 92868
        • Aún no reclutando
        • University of California Irvine
        • Contacto:
          • Christy L Hom, PhD
          • Número de teléfono: 714-456-5902
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Aún no reclutando
        • University of Colorado Anschutz Medical Campus
        • Contacto:
          • Joaquin Espinosa, PhD
          • Número de teléfono: 303-724-7389
    • Florida
      • Miami, Florida, Estados Unidos, 33136
        • Aún no reclutando
        • University of Miami
        • Contacto:
          • Ignacio Tapia, MD, MS
          • Número de teléfono: 305-243-6641
          • Correo electrónico: itapia@miami.edu
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Aún no reclutando
        • Kansas University Medical Center
        • Contacto:
          • Lauren T Ptomey, PhD, RD, LD
          • Número de teléfono: 913-588-5000
          • Correo electrónico: lptomey@kumc.edu
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Aún no reclutando
        • John Hopkins University
        • Contacto:
          • Sheela N Magge, MD, MSCE
          • Número de teléfono: 443-997-5437
          • Correo electrónico: smagge3@jhmi.edu
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Aún no reclutando
        • University of Minnesota
        • Contacto:
          • Jason Wolff, PhD
          • Número de teléfono: 612-625-4166
          • Correo electrónico: jjwolff@umn.edu
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63108
        • Aún no reclutando
        • Washington University in St. Louis
        • Contacto:
          • Natasha Marrus, MD
          • Número de teléfono: 314-286-1700
          • Correo electrónico: natasha@wustl.edu
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • Aún no reclutando
        • University of North Carolina at Chapel Hill
        • Contacto:
          • Heather Hazlett, PhD
          • Número de teléfono: 919-966-4099
          • Correo electrónico: cody@ad.unc.edu
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Aún no reclutando
        • The Children's Hospital of Philadelphia
        • Contacto:
          • Juhi Pandey, PhD
          • Número de teléfono: 215-590-7555
          • Correo electrónico: pandeyj@chop.edu
      • Pittsburgh, Pennsylvania, Estados Unidos, 15203
        • Aún no reclutando
        • University of Pittsburgh
        • Contacto:
          • Bejamin L Handen, PhD
          • Número de teléfono: 412-235-5445 Expertise
          • Correo electrónico: handenbl@upmc.edu
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38105
        • Aún no reclutando
        • St. Jude Children's Research Hospital
        • Contacto:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Aún no reclutando
        • Texas Children's Hosptial/Baylor College of Medicine
        • Contacto:
          • Mirjana Maletic-Savatic, MD, PhD
          • Número de teléfono: (832) 822-1700
          • Correo electrónico: maletics@bcm.edu
      • San Antonio, Texas, Estados Unidos, 78207
        • Aún no reclutando
        • University of Texas Health Science Center at San Antionio
        • Contacto:
          • Maria Rayas, MD
          • Número de teléfono: 210-358-5437
          • Correo electrónico: rayas@uthscsa.edu
    • Washington
      • Seattle, Washington, Estados Unidos, 98195
        • Aún no reclutando
        • University of Washington
        • Contacto:
          • Stephen Dager, MD
          • Número de teléfono: 877-408-UWAC
          • Correo electrónico: srd@uw.edu
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53705
        • Reclutamiento
        • University of Wisconsin-Madison
        • Contacto:
          • Sigan Hartley, PhD
          • Número de teléfono: 608.263.1656
          • Correo electrónico: slhartley@wisc.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Enrollment of Participants into the DS-CDP Common Protocol
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

RTI International

Colaboradores

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)

Investigadores

  • Investigador principal: Jessica E Hunter, PhD, RTI International

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2026

Finalización primaria (Estimado)

31 de agosto de 2029

Finalización del estudio (Estimado)

31 de agosto de 2029

Fechas de registro del estudio

Enviado por primera vez

11 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de mayo de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • DS-4C (36648)
  • 1U54HL178351 (Subvención/contrato del NIH de EE. UU.)
  • 1U01HD116485 (Subvención/contrato del NIH de EE. UU.)
  • 1U01HD116470 (Subvención/contrato del NIH de EE. UU.)
  • 1U01HD116469 (Subvención/contrato del NIH de EE. UU.)
  • 1U01HD116477 (Subvención/contrato del NIH de EE. UU.)
  • 1U01HD116463 (Subvención/contrato del NIH de EE. UU.)
  • 1U24AG092191 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

Ongoing, throughout the duration of the program

Criterios de acceso compartido de IPD

Through the INCLUDE Data HUB

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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