The Human Trisome Project

Research to Develop the Human Trisome Project Biobank

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02864108

Acronym

HTP

Enrollment

2500

Registered

2016-08-11

Start date

2016-07-31

Completion date

2036-07-31

Last updated

2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Trisomy 21

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 89 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactAngela Rachubinski, PhD

dsresearch@cuanschutz.edu(303) 724-7366

Backup ContactConstance Brecl, BA

dsresearch@cuanschutz.edu

Outcome results