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

NCT00968084 | Completed

• 2 other identifiers: 09020109-H-0201
• Study Type: observational
• Target: 587
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Disease; Autoimmune Disease; Immunologic Disease; Healthy Volunteers

Keywords

Diagnostic Work Up; Normal Volunteers; HV; Inflammatory Disease; Autoimmune Disease; Immunologic Disease; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Results of clinical, imaging and laboratory assessments.

Secondary Outcomes (1)

• Eligibility for participation on Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) tissue procurement of investigative therapy protocols.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with a disorder for which the CHI has an active research protocol, and based on information received from an outside physician, the patient appears to meet at least preliminary eligibility criteria for that protocol.
• Self proclaimed healthy volunteer for whom the CHI has a study actively recruiting healthy volunteers and he/she appears to meet preliminary eligibility as a healthy volunteer.
• Age greater than or equal to 2 (healthy volunteers greater than or equal to 8)
• Weight greater than 12 kg
• The subject or the subject s guardian is capable of informed consent, and willing to sign the consent form after initial counseling by clinical staff. Separate consent forms for all interventional or surgical procedures will be obtained after explanation of the specific procedure.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 29445374 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases; Immune System Diseases

Study Officials

• Neal S Young, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: August 6, 2009
• Study Completion: October 25, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10-25

Locations

US (1)