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NCT02864108 Clinical Trial

The Crnic Institute Human Trisome Project Biobank

Down Syndrome Clinical Trial

— HTP  

Official title:
Research to Develop the Human Trisome Project Biobank

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02864108
Other study ID # 15-2170
Secondary ID UL1TR001082
Status Recruiting
Phase
First received
Last updated
Start date July 2016
Est. completion date July 2036

Study information
Verified date April 2024
Source University of Colorado, Denver
Contact Angela Rachubinski, PhD
Phone (303) 724-7366
Email dsresearch@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2500
Est. completion date July 2036
Est. primary completion date July 2036
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 89 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Linda Crnic Institute for Down Syndrome at the University of Colorado Denver Denver Colorado

Sponsors (5)
Lead Sponsor Collaborator
University of Colorado, Denver Anna and John J. Sie Foundation, GLOBAL Down Syndrome Foundation, Linda Crnic Institute for Down Syndrome, National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants and Controls Enrolled in Biobank 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. 5 years
Secondary Number of Clinical Records Available for Approved Research Purposes Create a database of clinical information to pair with biological samples listed above. 5 years
Secondary Multidimensional Sample Characterization 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. 5 years
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