Screening Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Infectious Disease, Endocrine |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 10/29/2017 |
| Start Date: | August 6, 2009 |
| End Date: | October 25, 2017 |
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.
- 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.
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.
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.
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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