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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 : November 14, 2022
Sponsor:
Collaborator:
Linda Crnic Institute for Down Syndrome
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease
Down Syndrome Trisomy 21

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 Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research to Develop the Human Trisome Project Biobank
Study Start Date : July 2016
Estimated Primary Completion Date : July 2036
Estimated Study Completion Date : July 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
blood, saliva, mouth swab, urine (optional), stool (optional)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864108


Contacts
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Contact: Angela Rachubinski, PhD (303) 724-7366 dsresearch@cuanschutz.edu
Contact: Belinda Enriquez Estrada, MS (303) 724-0491 dsresearch@cuanschutz.edu

Locations
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United States, Colorado
Linda Crnic Institute for Down Syndrome at the University of Colorado Denver Recruiting
Denver, Colorado, United States, 80045
Principal Investigator: Joaquin Espinosa, PhD         
Sponsors and Collaborators
University of Colorado, Denver
Linda Crnic Institute for Down Syndrome
Investigators
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Principal Investigator: Joaquin Espinosa, PhD Linda Crnic Institute for Down Syndrome at the University of Colorado Denver
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02864108    
Other Study ID Numbers: 15-2170
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Down Syndrome
Trisomy
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
 Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication