The Crnic Institute Human Trisome Project Biobank (HTP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02864108|
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : September 26, 2019
|Condition or disease|
|Down Syndrome Trisomy 21|
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 Type :||Observational|
|Estimated Enrollment :||1500 participants|
|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|
Those with trisomy 21
People aged 6 months to 89 years old who have some form of trisomy 21.
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.
- 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.
- 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.
- 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
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
|Contact: Angela Rachubinski, PhD||(303) 724-7366||HTP@ucdenver.edu|
|Contact: Belinda Enriquez Estrada, BS||(303) 724-0491||HTP@ucdenver.edu|
|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|
|Principal Investigator:||Joaquin Espinosa, PhD||Linda Crnic Institute for Down Syndrome at the University of Colorado Denver|