Down Syndrome Clinical Trial
Official title:
Depressed AIRE Gene Expression Causes Immune Cell Dysfunction & Autoimmunity in Down Syndrome
NCT number | NCT02421276 |
Other study ID # | 14-2300 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 19, 2015 |
Est. completion date | February 2018 |
Verified date | April 2022 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study plans to learn more about Down syndrome. The investigators think there is a different level of the AIRE gene in individuals with Down syndrome. The investigators think that the AIRE gene level can provide more insight about depressed immune cell function in individuals with Down syndrome. Patients are being asked to be in this research study because the investigators want to see if their blood contains more of less of the AIRE gene.
Status | Completed |
Enrollment | 45 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 22 Years |
Eligibility | Inclusion Criteria: 1. Age newborn up until the twenty-second birthday. 2. Diagnosed with idiopathic or secondary pulmonary arterial hypertension as defined by a mean pulmonary artery pressure > 25 mmHg at rest or > 30 mmHg with exercise. 3. Confirmed trisomy 21. 4. Followed by the Pulmonary Hypertension Program and Sie Center at The Children's Hospital. 5. The investigator or co-investigator must obtain written informed consent and assent where applicable before any study procedure is performed or data is collected. Exclusion Criteria: 1. Any person older than 22 years of age 2. Patients with sickle cell disease with Pulmonary Arterial Hypertension (PAH) as treatment is defined differently within this population. 3. In the opinion of the investigator, a patient who is unlikely to cooperate or complete the study for any reason. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado, Denver | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AIRE Gene expression in Macrophage Subpopulations | Peripheral blood draw | At the time of sample acquisition | |
Secondary | White blood cell Subpopulation Numbers | Peripheral blood draw | At the time of sample acquisition |
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