Feasibility Study of Collecting Multicenter Chronic GVHD Data

NCT00506233 | Completed

• 1 other identifier: 2006-0541
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objective: 1\. To determine the feasibility of conducting a multi-site longitudinal observational study of patients with chronic graft-versus-host disease (GVHD).

Conditions

Graft-Versus-Host Disease

Keywords

Graft-Versus-Host Disease; GVHD; Questionnaire

Study Arms (1)

Chronic Graft-Versus Host Disease (GvHD)

Participants with chronic graft-versus host disease (GvHD)

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Completion of questionnaires at 3 different times (when joining this study, 3 months later, and 6 months later). Each should take about 20-30 minutes to complete.

Also known as: surveys

Chronic Graft-Versus Host Disease (GvHD)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic graft-versus host disease (GvHD) at UT MD Anderson Cancer Center.

You may qualify if:

• Age greater than or equal to 2 years
• Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis allowed
• If a prevalent case (defined as enrollment three or more months after chronic GVHD diagnosis), then subject must be within 2 years of stem cell infusion
• Diagnosis of chronic GVHD meeting the diagnostic criteria of the diagnosis and staging group of the NIH consensus conference
• Need for systemic treatment, defined as any medication or intervention delivered systemically, including extracorporeal photopheresis. If a patient only received topical or local therapy at diagnosis, but subsequently requires systemic treatment, they may be enrolled upon initiation of systemic therapy. (Note, these patients will be classified as incident or prevalent cases depending on time from chronic GVHD diagnosis, not start of systemic therapy)
• Progression-free for their malignancy at enrollment (no evidence of primary disease progression since transplant, although residual disease may still be present)
• Evaluation at the transplant center at the time of study enrollment, and agreement to be re-evaluated at the transplant center at 3 and 6 months
• Signed, informed consent and if applicable, child assent

You may not qualify if:

• Inability to verbally communicate in English
• Inability to comply with study procedures
• Anticipated survival less than 6 months due to co-morbid disease or persistent malignancy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amin Alousi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: August 1, 2006
• Primary Completion: September 1, 2007
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (2)