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
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|ClinicalTrials.gov Identifier: NCT01200823|
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : March 29, 2018
|First Submitted Date||September 10, 2010|
|First Posted Date||September 14, 2010|
|Last Update Posted Date||March 29, 2018|
|Study Start Date||July 1, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01200823 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief 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 Laboratory Research Studies|
|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|
- 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.
- 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.
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.
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.
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|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition||Idopathic Inflammatory/Autoimmune Syndromes|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Unaffected Child Relatives
Unaffected Adult Relatives
EXCLUSION CRITERIA: (All groups)
|Ages||2 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100162
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )|
|Study Sponsor||National Institute of Allergy and Infectious Diseases (NIAID)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 12, 2018|