HTP: The Crnic Institute Human Trisome Project Biobank

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT02864108

Collaborator

Linda Crnic Institute for Down Syndrome (Other)

1,500

Enrollment

Location

240

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Research to Develop the Human Trisome Project Biobank

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2036

Anticipated Study Completion Date :

Jul 1, 2036

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Anyone 6 months to 89 years old who:

has Down syndrome (any type)
does not have Down syndrome

Exclusion Criteria:

Prisoners
Wards of the state

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linda Crnic Institute for Down Syndrome at the University of Colorado Denver	Denver	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver
Linda Crnic Institute for Down Syndrome

Investigators

Principal Investigator: Joaquin Espinosa, PhD, Linda Crnic Institute for Down Syndrome at the University of Colorado Denver

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

The Human Trisome Project™

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02864108

Other Study ID Numbers:

15-2170
UL1TR001082

First Posted:

Aug 11, 2016

Last Update Posted:

Nov 9, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Down Syndrome

Trisomy

Study Results

No Results Posted as of Nov 9, 2021