NCT00968084

Screening Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols

Completed Last updated 27 October 2017

What this trial tests

trial in Inflammatory Disease in 587 participants. Completed in 25 October 2017.

Timeline

6 August 2009

25 October 2017

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	587
Start date	6 August 2009
Estimated completion	25 October 2017
Sites	1 location across United States

Conditions studied

• Inflammatory Disease — all drugs for Inflammatory Disease →
• Autoimmune Disease — all drugs for Autoimmune Disease →
• Immunologic Disease — all drugs for Immunologic Disease →
• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

2 and older, any sex, with Inflammatory Disease or Autoimmune Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* For every CHI research study, patients must fulfill a list of criteria, based primarily on their medical condition. To determine whether a patient meets these eligibility criteria to participate in a research protocol, researchers must perform a series of diagnostic tests and procedures.
* These evaluations are designed to evaluate a participant s general medical condition (i.e., blood tests, function of certain organs such as the lungs, heart, liver, or kidneys), and to confirm a diagnosis or ensure that a healthy volunteer is in good condition. They maximize the safety for the patients and healthy volunteers at CHI.

Objective:

\- To determine the eligibility of patients and healthy volunteers for active CHI research protocols.

Eligibility:

* The procedures included in this protocol will determine eligibility for active CHI research protocols.
* Both healthy volunteers and patients will be evaluated.

Design:

* Required tests and procedures for various research studies may include the following: history and physical examination, blood and urine tests, lung and heart function tests (echocardiogram, electrocardiogram, stress test), imaging studies (X-rays, magnetic resonance imaging (MRI), computerized tomography (CT), and tissue collection.
* Participants will be asked to undergo tests only for the study or studies for which they are being considered. The research team will provide further information on any additional tests that may be required.
* After all eligibility assessments are complete, participants may be offered participation in one or more CHI research protocols or referred back to a home physician.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of Systemically Administered Hydrocortisone on the Human Immunome.
   Olnes MJ, Kotliarov Y, Biancotto A, Cheung F, et al · · 2016 · cited 127× · PMID 26972611 · DOI 10.1038/srep23002
2. The Immunome in Two Inherited Forms of Pulmonary Fibrosis.
   El-Chemaly S, Cheung F, Kotliarov Y, O'Brien KJ, et al · · 2018 · cited 20× · PMID 29445374 · DOI 10.3389/fimmu.2018.00076