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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 5, 2007 | ||||||||
| Last Updated Date | August 21, 2009 | ||||||||
| Start Date ICMJE | November 2007 | ||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00569842 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Investigation of the Cylex® ImmuKnow® Assay | ||||||||
| Official Title ICMJE | Investigation of the Cylex® ImmuKnow® Assay | ||||||||
| Brief Summary | Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay to see if doctors can detect which patients are at risk for GvHD and for getting an infection before they occur. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case-Only, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | November 2010 | ||||||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00569842 | ||||||||
| Responsible Party | Sherif Farag, MD, PhD/ Principal Investigator, Indiana University Cancer Center | ||||||||
| Study ID Numbers ICMJE | 0710-11/ IUCRO-0207 | ||||||||
| Study Sponsor ICMJE | Indiana University School of Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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