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Collaboration for Down Syndrome Progress (CDP) (CDP)

2026년 5월 28일 업데이트: 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.

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

1400

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Jessica E Hunter, PhD
전화번호: 919 541 6000
이메일: jehunter@rti.org

연구 장소

미국
- California
  - Orange, California, 미국, 92868
    - 아직 모집하지 않음
    - University of California Irvine
    - 연락하다:
      
      Christy L Hom, PhD
      
      전화번호: 714-456-5902
- Colorado
  - Aurora, Colorado, 미국, 80045
    - 아직 모집하지 않음
    - University of Colorado Anschutz Medical Campus
    - 연락하다:
      
      Joaquin Espinosa, PhD
      
      전화번호: 303-724-7389
- Florida
  - Miami, Florida, 미국, 33136
    - 아직 모집하지 않음
    - University of Miami
    - 연락하다:
      
      Ignacio Tapia, MD, MS
      
      전화번호: 305-243-6641
      
      이메일: itapia@miami.edu
- Kansas
  - Kansas City, Kansas, 미국, 66160
    - 아직 모집하지 않음
    - Kansas University Medical Center
    - 연락하다:
      
      Lauren T Ptomey, PhD, RD, LD
      
      전화번호: 913-588-5000
      
      이메일: lptomey@kumc.edu
- Maryland
  - Baltimore, Maryland, 미국, 21287
    - 아직 모집하지 않음
    - John Hopkins University
    - 연락하다:
      
      Sheela N Magge, MD, MSCE
      
      전화번호: 443-997-5437
      
      이메일: smagge3@jhmi.edu
- Minnesota
  - Minneapolis, Minnesota, 미국, 55455
    - 아직 모집하지 않음
    - University of Minnesota
    - 연락하다:
      
      Jason Wolff, PhD
      
      전화번호: 612-625-4166
      
      이메일: jjwolff@umn.edu
- Missouri
  - St Louis, Missouri, 미국, 63108
    - 아직 모집하지 않음
    - Washington University in St. Louis
    - 연락하다:
      
      Natasha Marrus, MD
      
      전화번호: 314-286-1700
      
      이메일: natasha@wustl.edu
- North Carolina
  - Chapel Hill, North Carolina, 미국, 27599
    - 아직 모집하지 않음
    - University of North Carolina at Chapel Hill
    - 연락하다:
      
      Heather Hazlett, PhD
      
      전화번호: 919-966-4099
      
      이메일: cody@ad.unc.edu
- Pennsylvania
  - Philadelphia, Pennsylvania, 미국, 19104
    - 아직 모집하지 않음
    - The Children's Hospital of Philadelphia
    - 연락하다:
      
      Juhi Pandey, PhD
      
      전화번호: 215-590-7555
      
      이메일: pandeyj@chop.edu
  - Pittsburgh, Pennsylvania, 미국, 15203
    - 아직 모집하지 않음
    - University of Pittsburgh
    - 연락하다:
      
      Bejamin L Handen, PhD
      
      전화번호: 412-235-5445 Expertise
      
      이메일: handenbl@upmc.edu
- Tennessee
  - Memphis, Tennessee, 미국, 38105
    - 아직 모집하지 않음
    - St. Jude Children's Research Hospital
    - 연락하다:
      
      Lisa Jacola, PhD, ABPP-CN
      
      전화번호: 901-595-5042
      
      이메일: Lisa.Jacola@STJUDE.org
- Texas
  - Houston, Texas, 미국, 77030
    - 아직 모집하지 않음
    - Texas Children's Hosptial/Baylor College of Medicine
    - 연락하다:
      
      Mirjana Maletic-Savatic, MD, PhD
      
      전화번호: (832) 822-1700
      
      이메일: maletics@bcm.edu
  - San Antonio, Texas, 미국, 78207
    - 아직 모집하지 않음
    - University of Texas Health Science Center at San Antionio
    - 연락하다:
      
      Maria Rayas, MD
      
      전화번호: 210-358-5437
      
      이메일: rayas@uthscsa.edu
- Washington
  - Seattle, Washington, 미국, 98195
    - 아직 모집하지 않음
    - University of Washington
    - 연락하다:
      
      Stephen Dager, MD
      
      전화번호: 877-408-UWAC
      
      이메일: srd@uw.edu
- Wisconsin
  - Madison, Wisconsin, 미국, 53705
    - 모병
    - University of Wisconsin-Madison
    - 연락하다:
      
      Sigan Hartley, PhD
      
      전화번호: 608.263.1656
      
      이메일: slhartley@wisc.edu

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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.

그룹/코호트

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Enrollment of Participants into the DS-CDP Common Protocol 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

RTI International

협력자

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)

수사관

수석 연구원: Jessica E Hunter, PhD, RTI International

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

Related Info

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 1일

기본 완료 (추정된)

2029년 8월 31일

연구 완료 (추정된)

2029년 8월 31일

연구 등록 날짜

최초 제출

2026년 5월 11일

QC 기준을 충족하는 최초 제출

2026년 5월 28일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)