Screening Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols
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|ClinicalTrials.gov Identifier: NCT00968084|
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : October 27, 2017
|First Submitted Date||August 27, 2009|
|First Posted Date||August 28, 2009|
|Last Update Posted Date||October 27, 2017|
|Study Start Date||August 6, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Results of clinical, imaging and laboratory assessments.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00968084 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||Eligibility for participation on Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) tissue procurement of investigative therapy protocols.|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Screening Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols|
|Official Title||Screening Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols|
- To determine the eligibility of patients and healthy volunteers for active CHI research protocols.
This protocol is designed for screening of subjects prior to a decision as to their eligibility for participation on a Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) tissue procurement or investigative therapy protocol. The purpose of the protocol is to allow investigation into any underlying immunologic and/or inflammatory processes and to assess the status of organ systems, important both to determine suitability for participation on specific protocols and/or ability to safely tolerate tissue procurement or investigative treatments and procedures. It also allows the investigation as to whether subjects are eligible for participation as a volunteer based on eligibility criteria that include generally good health status by history and physical examination and laboratory assessment. After completion of the screening process, the subject will either be offered an opportunity to participate in a specific research protocol, or if no appropriate protocol is identified, will have recommendations for other treatment options conveyed to the primary or referring physician.
Primary objective is to determine subject eligibility for participation on Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) tissue procurement or investigative therapy protocols.
Primary endpoint is the results of clinical, imaging and laboratory assessments.
|Study Design||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||El-Chemaly S, Cheung F, Kotliarov Y, O'Brien KJ, Gahl WA, Chen J, Perl SY, Biancotto A, Gochuico BR. The Immunome in Two Inherited Forms of Pulmonary Fibrosis. Front Immunol. 2018 Jan 31;9:76. doi: 10.3389/fimmu.2018.00076. eCollection 2018.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||October 25, 2017|
|Primary Completion Date||Not Provided|
All subjects not fulfilling the inclusion criteria will be considered ineligible.
|Ages||2 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||090201
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )|
|Study Sponsor||National Heart, Lung, and Blood Institute (NHLBI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 25, 2017|