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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Autoimmune Disease; Inflammatory Disease; Immunologic Disease

Detailed Description

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 Type: Observational
• Enrollment (Actual): 587

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

• INCLUSION CRITERIA:

  1. 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.

     OR

     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.

  2. Age greater than or equal to 2 (healthy volunteers greater than or equal to 8)
  3. Weight greater than 12 kg
  4. 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.

EXCLUSION CRITERIA:

All subjects not fulfilling the inclusion criteria will be considered ineligible.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Results of clinical, imaging and laboratory assessments.

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 6, 2009
• Study Completion: October 25, 2017

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (Estimate): August 28, 2009

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 25, 2017

More Information

Terms related to this study

• Keywords: HV; Healthy Volunteer; Autoimmune Disease; Normal Volunteers; Inflammatory Disease; Diagnostic Work Up; Immunologic Disease
• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases
• Other Study ID Numbers: 090201; 09-H-0201