Idopathic Inflammatory/Autoimmune Syndromes Clinical Trial
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
| Verified date | September 18, 2018 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 96 |
| Est. completion date | September 18, 2018 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility |
- INCLUSION CRITERIA 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) 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. EXCLUSION CRITERIA: (All groups) - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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. — View Citation
Wolthers OD. A questionnaire on factors influencing children's assent and dissent to non-therapeutic research. J Med Ethics. 2006 May;32(5):292-7. — View Citation
Wood AJ, Darbyshire J. Injury to research volunteers--the clinical-research nightmare. N Engl J Med. 2006 May 4;354(18):1869-71. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |