Idopathic Inflammatory/Autoimmune SyndromesNCT01200823
Collection of Blood, Bone Marrow, Leukapheresis, and Tissue Biopsy Samples From Patients and Their Family Members for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases Laboratory Research Studies
An observational study of Idopathic Inflammatory/Autoimmune Syndromes, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) is conducting a variety of laboratory research experiments that require blood, bone marrow, urine, stool, and/or tissue samples from patients with a diagnosis of an immunologic, autoimmune, or inflammatory disorder, as well as… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Idopathic Inflammatory/Autoimmune Syndromes
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 18 Sep 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Affected Adults
- The subject carries the diagnosis of an immune-mediated or inflammatory disease, or has signs or symptoms of an immune or inflammatory disease without a formal diagnosis.
- Age 18 years and older (no upper limit)
- Affected Children
- The subject carries the diagnosis of an immune-mediated or inflammatory disease, or has signs or symptoms of an immune or inflammatory disease without a formal diagnosis.
- Age 2 years and older (no upper limit)
Show all 12Show fewer
- Unaffected Child Relatives
- Immediate family members (child, sibling, grandchild) of individuals included under item (Affected Adult)
- Subjects over 2 years of age may (but < 18 years of age) be seen for initial evaluations, genetic studies, or research blood specimens, or may send blood or buccal samples for genetic testing only. Unaffected family members will not be asked to undergo leukapheresis, bone marrow aspirations and biopsies, or other invasive procedures.
- Unaffected Adult Relatives
- Immediate family members (parent, child, sibling, grandchild) of individuals included under item (Affected Adult)
- Subjects over 18 years of age may be seen for initial evaluations, genetic studies, or research blood specimens, or may send blood or buccal samples for genetic testing only. Unaffected family members will not be asked to undergo leukapheresis, bone marrow aspirations and biopsies, or other invasive procedures.
Who cannot join
- Subjects or their parents or guardians who are unable to comprehend the investigational nature of the procedure. The subject or the subject s guardian is unable to understand the investigational nature of the study and provide informed consent after initial counseling by clinical staff. Only adults capable of signing consent will be eligible. Separate consent forms for all interventional or surgical procedures will be obtained after explanation of the specific procedure.
- Pregnant unaffected relatives will be excluded.
- Subjects not willing to participate in the genetic analysis and whole genomic analysis portion of this study.
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
Official title: Collection of Blood, Bone Marrow, Leukapheresis, and Tissue Biopsy Samples From Patients and Their Family Members for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Background:
- The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) is conducting a variety of laboratory research experiments that require blood, bone marrow, urine, stool, and/or tissue samples from patients with a diagnosis of an immunologic, autoimmune, or inflammatory disorder, as well as from their healthy relatives. Donated samples will be sent to the CHI laboratory at the National Institutes of Health to be used in research that may provide more information on the changes in the immune system caused by these specific disorders.
Read more
Objectives:
- To collect blood, leukapheresis cells, bone marrow, urine, stool, cheek swab, and tissue samples from patients with immune-mediated and inflammatory diseases, as well as from family members, for ongoing exploratory research studies.
Eligibility:
- Individuals at least 2 years of age who have been diagnosed with an immune-mediated or inflammatory disease, or have signs or symptoms of an immune or inflammatory disease without a formal diagnosis.
- Immediate family members (parent, child, sibling, grandchild) of the above mentioned individuals.
Design:
- Participants will be screened with a complete medical history, physical examination, and blood and urine samples.
- Participants will provide blood, urine, stool, cheek swab, and tissue samples as required by the study researchers.
- Participants who have immune or inflammatory diseases will also provide blood and bone marrow samples collected through biopsies and leukapheresis (to collect specific blood cells).
- Adult relatives will provide additional samples through more invasive procedures such as leukapheresis and bone marrow biopsies. Child relatives (between 2 and 18 years of age) will not undergo these invasive procedures.
- No treatment will be provided as part of this protocol.
Read the detailed description
BACKGROUND
Clinical investigators in the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) study the pathophysiology of a wide variety of immune-mediated and inflammatory diseases. One of the goals of the CHI is to better understand these diseases and to refine therapeutic approaches used in their management based on knowledge of the underlying pathophysiologies. This requires samples from patients with immune-mediated and inflammatory diseases for such clinical and laboratory assessments. Collection of samples from family members is necessary to identify genetic components of specific conditions.
We expect the great majority of publications from the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) over the next several decades will be generated from exploratory laboratory research studies done using blood and bone marrow and other tissue samples from such patients and their family members. These publications are expected to number in the hundreds. Ongoing and future research projects depend on the ready availability of samples of blood, tissue, leukapheresed cells, and bone marrow from patients for in vitro studies.
OBJECTIVE
To provide a mechanism for collection of blood, bone marrow, leukapheresis cells, urine, stool, buccal mucosa and/or tissue samples from patients with immune-mediated and inflammatory diseases, as well as from family members for ongoing exploratory research studies.
STUDY DESIGN
This study is not a treatment protocol. This is a sample and clinical data procurement protocol.
All subjects with conditions of interest seen at the NIH Clinical Center will first be enrolled onto CHI protocol 09-H-0201 Screening protocol for subjects being evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) protocols. Patients who require specific medical intervention will be enrolled on and receive treatment under another NIH or CHI Clinical Center protocol or will be under the care of their home health care provider. In exceptional cases in which it is not possible for patients to travel to the Clinical Center, they may be allowed the option of giving consent to provide samples for research studies, including genetic analyses, performed on blood, buccal mucosa, bone marrow, and tissue samples sent through their local physician without enrolling onto 09-H-0201. Information will be obtained retrospectively by review of medical records and examination of archived materials and/or prospectively by clinical examinations and laboratory tests. The protocol is written for an indefinite period of time with subject accrual to occur both at the NIH Clinical Center or through home health care providers (off site).
- Keywords
- Laboratory Research, Biologic Samples, Tissue Collection, Tissue Procurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Samples will be used for clinical and translational research in the CHI and are indispensable for many of our research projects, including understanding the pathophysiology of a wide variety of immune-mediated and inflammatory diseases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study start1 Jul 2010
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idopathic Inflammatory/Autoimmune SyndromesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Angelique Biancotto, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200823
- Sponsor's protocol ID
- 100162
- Other IDs
- 10-I-0162
- Status last verified
- 18 Sep 2018
- First submitted
- 10 Sep 2010
- Last updated
- 20 Sep 2018
- Results posted
- No
Publications
Cole M, Boddy AV, Kearns P, Teh KH, Price L, Parry A, Pearson AD, Veal GJ; UKCCSG Pharmacology group. Potential clinical impact of taking multiple blood samples for research studies in paediatric oncology: how much do we really know? Pediatr Blood Cancer. 2006 Jun;46(7):723-7. doi: 10.1002/pbc.20463.
PubMed 16007598Wood AJ, Darbyshire J. Injury to research volunteers--the clinical-research nightmare. N Engl J Med. 2006 May 4;354(18):1869-71. doi: 10.1056/NEJMp068082. No abstract available.
PubMed 16672696Wolthers OD. A questionnaire on factors influencing children's assent and dissent to non-therapeutic research. J Med Ethics. 2006 May;32(5):292-7. doi: 10.1136/jme.2004.010579.
PubMed 16648281El-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 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood, Bone Marrow, Leukapheresis, and Tissue Biopsy Samples From Patients and Their Family Members for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
- ClinicalTrials.gov ID
- NCT01200823
- Acronym / sponsor ID
- 100162
- Keywords
- Laboratory Research, Biologic Samples, Tissue Collection, Tissue Procurement
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 1 Jul 2010
- Study completion
- 18 Sep 2018
- First posted
- 14 Sep 2010 (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:
- The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) is conducting a variety of laboratory research experiments that require blood, bone marrow, urine, stool, and/or tissue samples from patients with a diagnosis of an immunologic, autoimmune, or inflammatory disorder, as well as from their healthy relatives. Donated samples will be sent to the CHI laboratory at the National Institutes of Health to be used in research that may provide more information on the changes in the immune system caused by these specific disorders.
Objectives:
- To collect blood, leukapheresis cells, bone marrow, urine, stool, cheek swab, and tissue samples from patients with immune-mediated and inflammatory diseases, as well as from family members, for ongoing exploratory research studies.
Eligibility:
- Individuals at least 2 years of age who have been diagnosed with an immune-mediated or inflammatory disease, or have signs or symptoms of an immune or inflammatory disease without a formal diagnosis.
- Immediate family members (parent, child, sibling, grandchild) of the above mentioned individuals.
Design:
- Participants will be screened with a complete medical history, physical examination, and blood and urine samples.
- Participants will provide blood, urine, stool, cheek swab, and tissue samples as required by the study researchers.
- Participants who have immune or inflammatory diseases will also provide blood and bone marrow samples collected through biopsies and leukapheresis (to collect specific blood cells).
- Adult relatives will provide additional samples through more invasive procedures such as leukapheresis and bone marrow biopsies. Child relatives (between 2 and 18 years of age) will not undergo these invasive procedures.
- No treatment will be provided as part of this protocol.
Detailed description
BACKGROUND
Clinical investigators in the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) study the pathophysiology of a wide variety of immune-mediated and inflammatory diseases. One of the goals of the CHI is to better understand these diseases and to refine therapeutic approaches used in their management based on knowledge of the underlying pathophysiologies. This requires samples from patients with immune-mediated and inflammatory diseases for such clinical and laboratory assessments. Collection of samples from family members is necessary to identify genetic components of specific conditions.
We expect the great majority of publications from the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) over the next several decades will be generated from exploratory laboratory research studies done using blood and bone marrow and other tissue samples from such patients and their family members. These publications are expected to number in the hundreds. Ongoing and future research projects depend on the ready availability of samples of blood, tissue, leukapheresed cells, and bone marrow from patients for in vitro studies.
OBJECTIVE
To provide a mechanism for collection of blood, bone marrow, leukapheresis cells, urine, stool, buccal mucosa and/or tissue samples from patients with immune-mediated and inflammatory diseases, as well as from family members for ongoing exploratory research studies.
STUDY DESIGN
This study is not a treatment protocol. This is a sample and clinical data procurement protocol.
All subjects with conditions of interest seen at the NIH Clinical Center will first be enrolled onto CHI protocol 09-H-0201 Screening protocol for subjects being evaluated for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) protocols. Patients who require specific medical intervention will be enrolled on and receive treatment under another NIH or CHI Clinical Center protocol or will be under the care of their home health care provider. In exceptional cases in which it is not possible for patients to travel to the Clinical Center, they may be allowed the option of giving consent to provide samples for research studies, including genetic analyses, performed on blood, buccal mucosa, bone marrow, and tissue samples sent through their local physician without enrolling onto 09-H-0201. Information will be obtained retrospectively by review of medical records and examination of archived materials and/or prospectively by clinical examinations and laboratory tests. The protocol is written for an indefinite period of time with subject accrual to occur both at the NIH Clinical Center or through home health care providers (off site).
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Affected Adults
- The subject carries the diagnosis of an immune-mediated or inflammatory disease, or has signs or symptoms of an immune or inflammatory disease without a formal diagnosis.
- Age 18 years and older (no upper limit)
- Affected Children
- The subject carries the diagnosis of an immune-mediated or inflammatory disease, or has signs or symptoms of an immune or inflammatory disease without a formal diagnosis.
Key exclusion criteria (3 listed)
- Subjects or their parents or guardians who are unable to comprehend the investigational nature of the procedure. The subject or the subject s guardian is unable to understand the investigational nature of the study and provide informed consent after initial counseling by clinical staff. Only adults capable of signing consent will be eligible. Separate consent forms for all interventional or surgical procedures will be obtained after explanation of the specific procedure.
- Pregnant unaffected relatives will be excluded.
- Subjects not willing to participate in the genetic analysis and whole genomic analysis portion of this study.
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
Samples will be used for clinical and translational research in the CHI and are indispensable for many of our research projects, including understanding the pathophysiology of a wide variety of immune-mediated and inflammatory diseases.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Background: PubMed 16007598Cole M, Boddy AV, Kearns P, Teh KH, Price L, Parry A, Pearson AD, Veal GJ; UKCCSG Pharmacology group. Potential clinical impact of taking multiple blood samples for research studies in paediatric oncology: how much do we really know? Pediatr Blood Cancer. 2006 Jun;46(7):723-7. doi: 10.1002/pbc.20463.
- Background: PubMed 16672696Wood AJ, Darbyshire J. Injury to research volunteers--the clinical-research nightmare. N Engl J Med. 2006 May 4;354(18):1869-71. doi: 10.1056/NEJMp068082. No abstract available.
- Background: PubMed 16648281Wolthers OD. A questionnaire on factors influencing children's assent and dissent to non-therapeutic research. J Med Ethics. 2006 May;32(5):292-7. doi: 10.1136/jme.2004.010579.
- 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.
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.
Angelique Biancotto, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Idopathic Inflammatory/Autoimmune Syndromes, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 12 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Sep 2018. 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 was stopped early. Results are not available in the source record.
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?
Samples will be used for clinical and translational research in the CHI and are indispensable for many of our research projects, including understanding the pathophysiology of a wide variety of immune-mediated and inflammatory diseases.. 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 NCT01200823, which also lists 4 linked publications.
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 20 Sep 2018.