Rationale and Design of the Chronic GVHD Cohort Study: Improving Outcomes Assessment in Chronic GVHD

被引:49
作者
Lee, Stephanie J. [1 ]
Flowers, Mary E. D. [1 ]
Martin, Paul J. [1 ]
Carpenter, Paul [1 ]
Hansen, John [1 ]
Chai, Xiaoyu [1 ]
Kurland, Brenda [1 ]
Storer, Barry [1 ]
Arai, Sally [2 ]
Johnston, Laura [2 ]
Miklos, David [2 ]
Weisdorf, Daniel [3 ]
Arora, Mukta [3 ]
Majhail, Navneet [3 ]
Cutler, Corey [4 ]
Jagasia, Madan [5 ]
Palmer, Jeanne [6 ]
Pidala, Joseph [7 ]
Westervelt, Peter [8 ]
Pusic, Iskra [8 ]
Giralt, Sergio [9 ]
Goldberg, Jenna [9 ]
Couriel, Daniel [10 ]
Kitko, Carrie [10 ]
Pavletic, Steven Z. [11 ]
Vogelsang, Georgia B. [11 ]
Gilman, Andrew [11 ]
Schultz, Kirk [11 ]
机构
[1] Fred Hutchinson Canc Res Ctr, Seattle, WA 98109 USA
[2] Stanford Univ, Stanford, CA 94305 USA
[3] Univ Minnesota, Minneapolis, MN 55455 USA
[4] Dana Farber Canc Inst, Boston, MA USA
[5] Vanderbilt Univ, Med Ctr, Nashville, TN USA
[6] Med Coll Wisconsin, Milwaukee, WI USA
[7] H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA
[8] Washington Univ, St Louis, MO 63130 USA
[9] Mem Sloan Kettering Canc Ctr, New York, NY USA
[10] Univ Michigan, Ann Arbor, MI 48109 USA
[11] Northwestern Univ, Evanston, IL 60208 USA
关键词
Chronic graft-versus-host disease; Allogeneic hematopoietic cell transplantation; Outcomes research; Observational clinical study; VERSUS-HOST-DISEASE; CONSENSUS DEVELOPMENT PROJECT; WORKING GROUP-REPORT; BONE-MARROW-TRANSPLANTATION; CHRONIC GRAFT; CLINICAL-TRIALS; CELL TRANSPLANTATION; COMORBIDITY INDEX; HEALTH; CRITERIA;
D O I
10.1016/j.bbmt.2011.05.007
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
In 2005, the National Institutes of Health sponsored a Consensus Development Project on Criteria for Clinical Trials in chronic graft-versus-host (cGVHD) to achieve consensus about key elements of cGVHD research, including definitions for diagnosis, severity scoring, and response measures. To test these proposed definitions, a multicenter prospective cohort study of people with cGVHD is ongoing. This study will evaluate the performance of proposed prognostic factors, measures of disease activity, and surrogate endpoints for therapeutic response. Data are collected at 6-month intervals in a heterogeneous population of patients reflecting modern transplant techniques and posttransplantation clinical management (target enrollment 672 with cGVHD from I 0 transplantation centers). This report describes the rationale, design, and methods of the cGVHD cohort study, and invites other investigators to collaborate with the Consortium to analyze data or specimens. Biol Blood Marrow Transplant 17: 1114-1120 (2011) (C) 2011 American Society for Blood and Mal-row Transplantation.
引用
收藏
页码:1114 / 1120
页数:7
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