Inflammatory DiseaseNCT00968084
Screening Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols
An observational study of Inflammatory Disease and Autoimmune Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Disease, Autoimmune Disease, Immunologic Disease
- How many people
- 587 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2009to 25 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- Age greater than or equal to 2 (healthy volunteers greater than or equal to 8)
- Weight greater than 12 kg
- 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.
Who cannot join
- All subjects not fulfilling the inclusion criteria will be considered ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Keywords
- Diagnostic Work Up, Normal Volunteers, HV, Inflammatory Disease, Autoimmune Disease, Immunologic Disease, Healthy Volunteer
- Medical subject headings
- Autoimmune Diseases, Immune System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of clinical, imaging and laboratory assessments.
Secondary outcomes (1)
Eligibility for participation on Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) tissue procurement of investigative therapy protocols.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study start6 Aug 2009
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neal S Young, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968084
- Sponsor's protocol ID
- 090201
- Other IDs
- 09-H-0201
- Status last verified
- 25 Oct 2017
- First submitted
- 27 Aug 2009
- Last updated
- 27 Oct 2017
- Results posted
- No
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.
PubMed 29445374
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Protocol for Subjects Being Evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Protocols
- ClinicalTrials.gov ID
- NCT00968084
- Acronym / sponsor ID
- 090201
- Keywords
- Diagnostic Work Up, Normal Volunteers, HV, Inflammatory Disease, Autoimmune Disease, Immunologic Disease, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 6 Aug 2009
- Study completion
- 25 Oct 2017
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Other
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- All subjects not fulfilling the inclusion criteria will be considered ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Results of clinical, imaging and laboratory assessments.
1 secondary outcome
Eligibility for participation on Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) tissue procurement of investigative therapy protocols.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 29445374El-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.
Related trials for Inflammatory Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
RecruitingObservational study
Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study
Inflammatory Bowel Diseases, Crohn Disease
RecruitingPhase 2
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Ulcerative Colitis, Inflammatory Bowel Diseases
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal S Young, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Disease and Autoimmune Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of clinical, imaging and laboratory assessments.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017; AzTrials last refreshed its copy on 28 Oct 2026.