The Crnic Institute Human Trisome Project Biobank

Recruiting

• Conditions: Trisomy 21; Down Syndrome

• Registration Number: NCT02864108
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-21
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2036-07
• Study Completion: 2036-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants and Controls Enrolled in Biobank	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

Name	Time	Method
Number of Clinical Records Available for Approved Research Purposes	5 years	Create a database of clinical information to pair with biological samples listed above.
Multidimensional Sample Characterization	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.

Trial Locations

Locations (1)

Linda Crnic Institute for Down Syndrome at the University of Colorado Denver; 🇺🇸 Denver, Colorado, United States