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Collaboration for Down Syndrome Progress (CDP) (CDP)

2026年5月28日 更新者：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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

1400

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Jessica E Hunter, PhD
  • 电话号码：919 541 6000
  • 邮箱：jehunter@rti.org

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Enrollment of Participants into the DS-CDP Common Protocol
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

RTI International

合作者

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)

调查人员

  • 首席研究员：Jessica E Hunter, PhD、RTI International

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (估计的)

2029年8月31日

研究完成 (估计的)

2029年8月31日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • DS-4C (36648)
  • 1U54HL178351 (美国 NIH 拨款/合同)
  • 1U01HD116485 (美国 NIH 拨款/合同)
  • 1U01HD116470 (美国 NIH 拨款/合同)
  • 1U01HD116469 (美国 NIH 拨款/合同)
  • 1U01HD116477 (美国 NIH 拨款/合同)
  • 1U01HD116463 (美国 NIH 拨款/合同)
  • 1U24AG092191 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

IPD 共享时间框架

Ongoing, throughout the duration of the program

IPD 共享访问标准

Through the INCLUDE Data HUB

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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