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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center University of Minnesota Stanford University Dana-Farber Cancer Institute Children's Memorial Hospital Vanderbilt University National Institutes of Health (NIH) |
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Information provided by: | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00637689 |
The purpose of this study is to see if recent guidelines proposed by the National Institutes of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can improve our understanding of this complication. We will accomplish our goals by studying a large number of people with chronic GVHD over several years using information collected from health care providers, patients, laboratory studies and diagnostic tests.
Several transplant centers in the United States are collaborating on this project.
Condition |
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Chronic Graft Versus Host Disease |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Improving Outcomes Assessment in Chronic GVHD |
Some centers are collecting serum, plasma, cells and urine.
Estimated Enrollment: | 672 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Chronic graft-versus-host disease (GVHD) is one of the most devastating long-term complications after infusion of allogeneic hematopoietic stem cells, and it remains one of the major barriers to successful transplantation. Relatively little progress has been made in understanding and improving treatments for chronic GVHD over the last 20 years, and the survival rate after diagnosis of chronic GVHD has barely improved despite advances in supportive care. The National Institutes of Health convened a Consensus Conference on this topic in June 2004 and recently published its recommendations on improving research methods in a series of six papers. In our study, we will establish a multi-center, observational, longitudinal cohort in order to improve outcomes assessment in chronic GVHD with the specific aims of (1) validating prognostic factors for risk stratification; and (2) defining significant variables for a chronic GVHD activity index that predicts short-term (provider perception of change, patient perception of change, and changes in immunosuppressive medications) and longer-term outcomes (overall survival, time to discontinuation of systemic immunosuppressive therapy, and functional impairments). This goal will be accomplished by assembling a large modern cohort of people with chronic GVHD at four large core transplant centers. Approximately 700 people (half prevalent cases, half incident cases) with chronic GVHD will be enrolled. Every 3-6 months we will collect both objective and subjective measures reflecting disease activity, response to therapy, detailed physician assessments about organ involvement, and patient self-assessments about symptoms, functional status, and quality of life. Data will be used to test published hypotheses and the new recommendations emanating from the NIH Consensus conference. We will also be able to provide the detailed data needed to understand modern trends in chronic GVHD incidence, manifestations, and response to treatment. These studies are needed to operationalize the recommendations of the NIH Consensus conference, advance our understanding of chronic GVHD, and enhance our ability to conduct clinical trials.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
People with chronic GVHD
Inclusion Criteria:
Exclusion Criteria:
Contact: Kate Chilson | 866-379-4318 | kchilson@fhcrc.org |
Contact: Stephanie Lee, MD MPH | 206-667-5160 | sjlee@fhcrc.org |
United States, California | |
Stanford University | Recruiting |
Stanford, California, United States, 94305 | |
Principal Investigator: Sally Arai, MD | |
United States, Illinois | |
Children's Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60614 | |
Principal Investigator: David Jacobsohn, MD | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Corey Cutler, MD MS | |
United States, Minnesota | |
University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Principal Investigator: Mukta Arora, MD MS | |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Principal Investigator: Madan Jagasia, MD | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Principal Investigator: Stephanie J Lee, MD MPH |
Principal Investigator: | Stephanie J Lee, MD MPH | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Stephanie Lee/Principal Investigator ) |
Study ID Numbers: | FHCRC-2192.00, U01 CA 118953-01A1,, IR-6531 |
Study First Received: | March 12, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00637689 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chronic graft versus host disease Allogeneic hematopoietic cell transplantation Biomarkers |
Response criteria Surrogate endpoints Natural history |
Graft Versus Host Disease Graft vs Host Disease Homologous Wasting Disease |
Immune System Diseases Graft vs Host Disease |