Pilot Study: The Role of Migration Inhibitory Factor (MIF) in Spinal Cord Injury
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 10, 2009 | ||||||||
| Last Updated Date | September 10, 2012 | ||||||||
| Start Date ICMJE | May 2009 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00919581 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pilot Study: The Role of Migration Inhibitory Factor (MIF) in Spinal Cord Injury | ||||||||
| Official Title ICMJE | Pilot Study: The Role of MIF in Spinal Cord Injury | ||||||||
| Brief Summary | The purpose of this study is to evaluate substances that may be present in the blood after a spinal cord injury (SCI). Specifically, the study will evaluate the presence and levels of a protein, macrophage migration inhibitory factor (MIF), in the blood of patients who have had a SCI. Blood samples from patients who have had a SCI and healthy individuals will be studied to measure MIF levels. MIF is released by cells and has a specific effect on the way cells behave, communicate and work together. In several other medical conditions, MIF is known to increase inflammation in the body. By comparing blood samples from spinal cord injury patients and normal healthy individuals, the investigators will try to find out if MIF levels are increased in people with SCI. Investigators will also use these samples to see if the biological activities of MIF can be reduced in a test tube by adding other substances to the blood samples. It is hoped that this study of MIF will help improve the treatment of SCI in the future. We hope to enroll a total of 75 subjects in this study (50 with spinal cord injury, 25 healthy individuals). |
||||||||
| Detailed Description | During the study visit the investigator will collect basic biographical information and health information from the subjects medical record. The subjects will also have blood drawn (approximately 1 tablespoon) once in the morning and once in the evening. Whenever possible, this blood will be collected at the time of a regularly scheduled blood draw so no extra "stick" will be needed. It is possible if the doctor treating the SCI orders a spinal tap be done as a part of routine medical care, that one or two drops of the fluid that surrounds the spinal cord that would have been discarded, will instead be kept for analysis |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Subjects with spinal cord injury, healthy controls |
||||||||
| Condition ICMJE | Spinal Cord Injury | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 75 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: SCI Subject Inclusion Criteria: To be eligible for prospective enrollment, subjects are required to meet the following inclusion criteria:
Healthy Control Subject Inclusion Criteria: To be eligible for prospective enrollment, healthy control subjects are required to meet the following inclusion criteria:
Exclusion Criteria: SCI Subject Exclusion Criteria: To be eligible for prospective enrollment, subjects are required to not meet the following exclusion criteria:
Healthy Control Subject Exclusion Criteria: To be eligible for prospective enrollment, healthy control subjects are required to not meet the following exclusion criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00919581 | ||||||||
| Other Study ID Numbers ICMJE | 0268 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ona Bloom, North Shore Long Island Jewish Health System | ||||||||
| Study Sponsor ICMJE | North Shore Long Island Jewish Health System | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | North Shore Long Island Jewish Health System | ||||||||
| Verification Date | September 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||