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

National Institutes of Health (NIH)

Status: Completed

Conditions: Healthy Volunteers; Autoimmune Disease; Immunologic Disease; Inflammatory Disease

Study type: Observational

Funder types: NIH

Identifiers

NCT00968084

09-H-0201

090201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 587 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.