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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA163438 | U.S. NIH Grant/Contract | View source | |
| RDCRN-6501 | Other Identifier | DMCC | |
| 2342.00 | Other Identifier | FHCRC |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to better understand the onset and course of graft versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.
Allogeneic hematopoietic cell transplantation (HCT) is the only known curative option for many hematologic disorders. After transplantation, many patients develop immune mediated disorders that may be life-threatening such as graft versus host disease (GVHD). The morbidity and mortality associated with HCT-associated immune mediated disorders are major barriers to successful use of transplantation to cure rare hematologic malignancies such as leukemia, lymphoma, multiple myeloma, myelodysplastic/myeloproliferative syndromes amongst other diseases.
With this study, the investigators will investigate the biologic basis for immune mediated disorders after allogeneic HCT, focusing on those developing cutaneous sclerosis, bronchiolitis obliterans syndrome, late acute GVHD and chronic GVHD. The study will enroll 1118 (1018 adults and 100 children) allogeneic HCT patients over a three year period. Subjects will be followed for two years and monitored closely for development of immune mediated disorders. This study will have 5 study visits at day 1, 100, 180, 365, and 730. During these visits, a physical assessment, medication review, blood and urine collection will occur.
If a subject develops an immune mediated disordered, they will be monitored at 3 months, 6 months, 1 year and then annually from the date of diagnosis. During these study visits, a physical assessment, IMD status, and medication review as well as blood and urine collection will occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | Never develop an immune mediated disorder | ||
| Immune Mediated Disorder | Develop an immune mediated disorder |
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| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of immune mediated disorders | The prevalence of:
| Diagnosis of IMD and at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Banked blood and urine samples | Summarized as the percentage of compliance for each center and for the study as a whole | At 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are preparing for or have recently received an allogeneic hematopoietic cell transplant
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Lee, MD, MPH | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85054 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16338616 | Background | Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004. |
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blood and urine specimens
| Stanford |
| California |
| 94305 |
| United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University St. Louis | St Louis | Missouri | 63110 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D001989 | Bronchiolitis Obliterans |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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