Collaboration for Down Syndrome Progress (CDP) (CDP)
The INCLUDE (INvestigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome) Project's Collaboration for Down Syndrome Progress (CDP) Program
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jessica E Hunter, PhD
- 電話番号：919 541 6000
- メール：jehunter@rti.org
研究場所
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California
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Orange、California、アメリカ、92868
- まだ募集していません
- University of California Irvine
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コンタクト：
- Christy L Hom, PhD
- 電話番号：714-456-5902
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Colorado
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Aurora、Colorado、アメリカ、80045
- まだ募集していません
- University of Colorado Anschutz Medical Campus
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コンタクト：
- Joaquin Espinosa, PhD
- 電話番号：303-724-7389
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Florida
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Miami、Florida、アメリカ、33136
- まだ募集していません
- University of Miami
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コンタクト：
- Ignacio Tapia, MD, MS
- 電話番号：305-243-6641
- メール：itapia@miami.edu
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Kansas
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Kansas City、Kansas、アメリカ、66160
- まだ募集していません
- Kansas University Medical Center
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コンタクト：
- Lauren T Ptomey, PhD, RD, LD
- 電話番号：913-588-5000
- メール：lptomey@kumc.edu
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Maryland
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Baltimore、Maryland、アメリカ、21287
- まだ募集していません
- John Hopkins University
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コンタクト：
- Sheela N Magge, MD, MSCE
- 電話番号：443-997-5437
- メール：smagge3@jhmi.edu
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- まだ募集していません
- University of Minnesota
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コンタクト：
- Jason Wolff, PhD
- 電話番号：612-625-4166
- メール：jjwolff@umn.edu
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Missouri
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St Louis、Missouri、アメリカ、63108
- まだ募集していません
- Washington University in St. Louis
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コンタクト：
- Natasha Marrus, MD
- 電話番号：314-286-1700
- メール：natasha@wustl.edu
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- まだ募集していません
- University of North Carolina at Chapel Hill
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コンタクト：
- Heather Hazlett, PhD
- 電話番号：919-966-4099
- メール：cody@ad.unc.edu
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- まだ募集していません
- The Children's Hospital of Philadelphia
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コンタクト：
- Juhi Pandey, PhD
- 電話番号：215-590-7555
- メール：pandeyj@chop.edu
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Pittsburgh、Pennsylvania、アメリカ、15203
- まだ募集していません
- University of Pittsburgh
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コンタクト：
- Bejamin L Handen, PhD
- 電話番号：412-235-5445 Expertise
- メール：handenbl@upmc.edu
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- まだ募集していません
- St. Jude Children's Research Hospital
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コンタクト：
- Lisa Jacola, PhD, ABPP-CN
- 電話番号：901-595-5042
- メール：Lisa.Jacola@STJUDE.org
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Texas
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Houston、Texas、アメリカ、77030
- まだ募集していません
- Texas Children's Hosptial/Baylor College of Medicine
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コンタクト：
- Mirjana Maletic-Savatic, MD, PhD
- 電話番号：(832) 822-1700
- メール：maletics@bcm.edu
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San Antonio、Texas、アメリカ、78207
- まだ募集していません
- University of Texas Health Science Center at San Antionio
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コンタクト：
- Maria Rayas, MD
- 電話番号：210-358-5437
- メール：rayas@uthscsa.edu
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Washington
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Seattle、Washington、アメリカ、98195
- まだ募集していません
- University of Washington
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コンタクト：
- Stephen Dager, MD
- 電話番号：877-408-UWAC
- メール：srd@uw.edu
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Wisconsin
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Madison、Wisconsin、アメリカ、53705
- 募集
- University of Wisconsin-Madison
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コンタクト：
- Sigan Hartley, PhD
- 電話番号：608.263.1656
- メール：slhartley@wisc.edu
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Enrollment of Participants into the DS-CDP Common Protocol
時間枠：4 years
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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
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4 years
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Jessica E Hunter, PhD、RTI International
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- DS-4C (36648)
- 1U54HL178351 (米国 NIH グラント/契約)
- 1U01HD116485 (米国 NIH グラント/契約)
- 1U01HD116470 (米国 NIH グラント/契約)
- 1U01HD116469 (米国 NIH グラント/契約)
- 1U01HD116477 (米国 NIH グラント/契約)
- 1U01HD116463 (米国 NIH グラント/契約)
- 1U24AG092191 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。