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The Crnic Institute Human Trisome Project Biobank (HTP)

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ClinicalTrials.gov Identifier: NCT02864108
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Linda Crnic Institute for Down Syndrome
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date July 21, 2016
First Posted Date August 11, 2016
Last Update Posted Date September 26, 2019
Study Start Date July 2016
Estimated Primary Completion Date July 2036   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2019)
Number of Participants and Controls Enrolled in Biobank [ Time Frame: 5 years ]
Create biobank of blood cells and plasma, saliva, mouth swab, urine, stool, and induced pluripotent stem cells (iPSC) cells for use in approved research projects.
Original Primary Outcome Measures
 (submitted: August 8, 2016)
  • Number of Participants and Controls Enrolled in Biobank [ Time Frame: 4 years ]
    Create biobank of blood products and induced pluripotent stem cells (iPSC) cells for use in approved research projects.
  • Number of clinical records available for approved research purposes [ Time Frame: 4 years ]
    Create a database of clinical information to pair with biological information listed above.
Change History
Current Secondary Outcome Measures
 (submitted: February 4, 2019)
  • Number of Clinical Records Available for Approved Research Purposes [ Time Frame: 5 years ]
    Create a database of clinical information to pair with biological samples listed above.
  • Multidimensional Sample Characterization [ Time Frame: 5 years ]
    Characterize biological samples with multidimensional cellular and molecular analyses to generate the most thoroughly characterized set of samples from individuals with Down syndrome in the world.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Crnic Institute Human Trisome Project Biobank
Official Title Research to Develop the Human Trisome Project Biobank
Brief Summary The Human Trisome Project will significantly increase the speed of Down syndrome research and the understanding of associated medical conditions. Its biobank will provide de-identified samples to research.
Detailed Description

The purpose of this study is to provide qualified and approved researchers with access to biological samples and health information to answer specific research questions. This project will significantly increase the speed of Down syndrome research and the understanding of associated medical conditions such as Alzheimer's disease, congenital heart defects, autoimmune disorders, autism, and some forms of leukemia.

Participation includes a blood draw, a mouth swab, and allowing researchers to look at your health information yearly for the next 5 years. Optional procedures include providing a urine and/or stool sample and taking part in the study for a longer time frame.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood, saliva, mouth swab, urine (optional), stool (optional)
Sampling Method Non-Probability Sample
Study Population Individuals with Down syndrome, individuals related to someone with Down syndrome or of the general population who do not have a relationship to Down syndrome.
Condition
  • Down Syndrome
  • Trisomy 21
Intervention Not Provided
Study Groups/Cohorts
  • Those with trisomy 21
    People aged 6 months to 89 years old who have some form of trisomy 21.
  • Controls
    People aged 6 months to 89 years old who do not have trisomy 21. These persons can be related to someone with some form of trisomy 21 but do not have to be related.
Publications * Waugh KA, Araya P, Pandey A, Jordan KR, Smith KP, Granrath RE, Khanal S, Butcher ET, Estrada BE, Rachubinski AL, McWilliams JA, Minter R, Dimasi T, Colvin KL, Baturin D, Pham AT, Galbraith MD, Bartsch KW, Yeager ME, Porter CC, Sullivan KD, Hsieh EW, Espinosa JM. Mass Cytometry Reveals Global Immune Remodeling with Multi-lineage Hypersensitivity to Type I Interferon in Down Syndrome. Cell Rep. 2019 Nov 12;29(7):1893-1908.e4. doi: 10.1016/j.celrep.2019.10.038.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 4, 2019)
1500
Original Estimated Enrollment
 (submitted: August 8, 2016)
1000
Estimated Study Completion Date July 2036
Estimated Primary Completion Date July 2036   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Anyone 6 months to 89 years old who:

  1. has Down syndrome (any type)
  2. does not have Down syndrome

Exclusion Criteria:

  1. Prisoners
  2. Wards of the state
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 89 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Angela Rachubinski, PhD (303) 724-7366 HTP@ucdenver.edu
Contact: Belinda Enriquez Estrada, BS (303) 724-0491 HTP@ucdenver.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02864108
Other Study ID Numbers 15-2170
UL1TR001082 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Linda Crnic Institute for Down Syndrome
Investigators
Principal Investigator: Joaquin Espinosa, PhD Linda Crnic Institute for Down Syndrome at the University of Colorado Denver
PRS Account University of Colorado, Denver
Verification Date September 2019