Protocol Number: 09-HI-0201

Title:

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

Number:

09-HI-0201

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.

Sponsoring Institute:

Center for Human Immunology (CHI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

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.

Special Instructions:

Currently Not Provided

Keywords:

Diagnostic Work Up

Normal Volunteers

Recruitment Keyword(s):

HV

Inflammatory Disease

Autoimmune Disease

Immunologic Disease

Healthy Volunteer

Condition(s):

Inflammatory Disease

Autoimmune Disease

Immunologic Disease

Healthy Volunteers

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

Center for Human Immunology

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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