Disease Modifying Genes in Severe Asthma
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 19, 2005 | ||||
| Last Updated Date | April 18, 2013 | ||||
| Start Date ICMJE | April 2002 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To recruit and characterize a cohort of subjects with asthma who reside in a high pollution, high asthma risk neighborhood [ Time Frame: five yeARS ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00212537 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Disease Modifying Genes in Severe Asthma | ||||
| Official Title ICMJE | Disease Modifying Genes in Severe Asthma | ||||
| Brief Summary | Gene and protein bank to study disease modifying and susceptibility genes and proteins in urban patients with asthma. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: The total amount of blood drawn is approximately 5 tablespoons (75 ml). The blood sample will be processed to isolate "genetic material" (mainly DNA, RNA and protein). This genetic material will be used to try to identify the "genetic factors" or genes that a person inherits that make him or her more likely to develop asthma. The blood is used to test for allergies to weeds, trees, insects and molds (RAST) and a complete blood count. |
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All individuals approached for participation in the Research Registry shall be able to read or comprehend English. Since participation in the Research Registry does not involve a risk of physical harm, women of childbearing potential will not be queried as to pregnancy status or tested for pregnancy unless they are requested to undergo a methacholine challenge test. There are no additional inclusion/exclusion criteria. |
||||
| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 2000 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00212537 | ||||
| Other Study ID Numbers ICMJE | H9698 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | New York University School of Medicine | ||||
| Study Sponsor ICMJE | New York University School of Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | New York University School of Medicine | ||||
| Verification Date | April 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||