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Investigation of the Cylex® ImmuKnow® Assay

This study is currently recruiting participants.
Verified by Indiana University, July 2008

Sponsored by: Indiana University School of Medicine
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00569842
  Purpose

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.


Condition
Leukemia
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Hodgkin's Disease
Multiple Myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Aplastic Anemia
Chronic Myelogenous Leukemia

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Anemia    Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Investigation of the Cylex® ImmuKnow® Assay

Further study details as provided by Indiana University:

Biospecimen Retention:   None Retained

Biospecimen Description:

None to be retained.


Estimated Enrollment:   30
Study Start Date:   November 2007
Estimated Study Completion Date:   November 2010
Estimated Primary Completion Date:   November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
observational

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:

  1. Acute leukemia
  2. Non-Hodgkin's Lymphoma
  3. Chronic lymphocytic leukemia
  4. Hodgkin's disease
  5. Multiple myeloma
  6. Myelodysplastic Syndromes
  7. Myeloproliferative Disorders
  8. Aplastic Anemia
  9. Chronic myelogenous leukemia

Criteria

Inclusion Criteria:

Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:

  1. Acute leukemia
  2. Non-Hodgkin's Lymphoma
  3. Chronic lymphocytic leukemia
  4. Hodgkin's disease
  5. Multiple myeloma
  6. Myelodysplastic Syndromes
  7. Myeloproliferative Disorders
  8. Aplastic Anemia
  9. Chronic myelogenous leukemia
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569842

Contacts
Contact: Lisa Wood, RN     317-274-1781     llwood@iupui.edu    
Contact: Sherif Farag, MD, PhD     317-274-0843     ssfarag@iupui.edu    

Locations
United States, Indiana
Indiana Universtiy Simon Cancer Center     Recruiting
      Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators
Indiana University School of Medicine

Investigators
Principal Investigator:     Sherif Farag, MD, PhD     Indiana University Simon Cancer Center    
  More Information

Indiana University Simon Cancer Center: Find a Clinical Trial  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Indiana University Cancer Center ( Sherif Farag, MD, PhD/ Principal Investigator )
Study ID Numbers:   0710-11/IUCRO-0207
First Received:   December 5, 2007
Last Updated:   July 30, 2008
ClinicalTrials.gov Identifier:   NCT00569842
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Leukemia, Lymphoid
Hodgkin's disease
Chronic myelogenous leukemia
Precancerous Conditions
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Paraproteinemias
Hemostatic Disorders
Leukemia
Preleukemia
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Anemia, Aplastic
Hodgkin Disease
Lymphoma
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Myelodysplasia
Myelodysplastic Syndromes
Anemia
Myeloproliferative Disorders
Vascular Diseases
Leukemia, Myeloid
Multiple Myeloma
Lymphatic Diseases
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type
Immune System Diseases
Blood Protein Disorders
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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