Screening Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols
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||Inflammatory Disease - Autoimmune Disease - Immunologic Disease - Healthy Volunteers
- 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.
- To determine the eligibility of patients and healthy volunteers for active CHI research
- The procedures included in this protocol will determine eligibility for active CHI
- Both healthy volunteers and patients will be evaluated.
- 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
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.
- 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.
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.
All subjects not fulfilling the inclusion criteria will be considered ineligible.
Neal S Young, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
||Bethesda, Maryland 20892
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Site Status: N/A
||December 05, 2016
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