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CompletedNCT00506233Updated Jul 31, 2012

Feasibility Study of Collecting Multicenter Chronic GVHD Data

An observational study in Graft-Versus-Host Disease, sponsored by M.D. Anderson Cancer Center. Completed at 2 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2012-07-31.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13
Ages
2 Years and older
Sex
All
01

Study 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).

Read the detailed description

If you agree to take part in this study, you will be asked to fill-out some questionnaires, and your medical records will be reviewed. Your doctor or healthcare provider will also be asked to complete a questionnaire.

You will be asked to fill-out questionnaires at 3 different times (when you join this study, 3 months later, and 6 months later). The questionnaires will include questions about how your chronic GvHD impacts your body, your day-to-day activities, your emotions and perceptions, and your social and sexual life. Each questionnaire has 195 questions. Each should take about 20-30 minutes to complete, but you will also be asked how long it takes you to complete each questionnaire. For most participants, these visits will be part of your routine schedule for follow-up for the disease.

You have several options for where you may choose to complete the questionnaires. They may be completed when you visit the doctor for your appointments, at home (you will have to mail them back in self-addressed stamped envelopes that will be provided to you), or over the internet. If you are interested in the internet option, please ask study staff for more details. If at any time, your healthcare provider does not think it would be in your best interest to receive a survey at one of your scheduled time points, you will not be given a survey at that time, and you will be taken off this study.

Your healthcare provider will be asked to fill-out a questionnaire that asks about what was found on your physical exam and routine laboratory tests, what medications you are taking, and how severe your chronic GvHD is at that clinic visit.

Your medical records will be reviewed for about 1 year after your enrollment in this study to collect information about your stem cell transplant procedure, your medications, your medical condition, and the results of tests and procedures. The reviewing of your medical records does not require your active participation.

You will be on this study until you have completed the 6-month questionnaire.

This is an investigational study. There is no cost involved for participation in this study. Up to 40 participants will take part in this multicenter study. Up to 15 will be enrolled M. D. Anderson.

02

Conditions studied

  • Graft-Versus-Host Disease

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Keywords

  • Graft-Versus-Host Disease
  • GVHD
  • Questionnaire
03

In context

Graft vs Host Disease

815 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

This study's enrollment of 13 is below the median of 82 across 104 observational studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.

Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age greater than or equal to 2 years
  2. Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis allowed
  3. 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
  4. Diagnosis of chronic GVHD meeting the diagnostic criteria of the diagnosis and staging group of the NIH consensus conference
  5. 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)
  6. Progression-free for their malignancy at enrollment (no evidence of primary disease progression since transplant, although residual disease may still be present)
  7. 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
  8. Signed, informed consent and if applicable, child assent

Exclusion criteria

Exclusion Criteria:

  1. Inability to verbally communicate in English
  2. Inability to comply with study procedures
  3. Anticipated survival less than 6 months due to co-morbid disease or persistent malignancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13 participants (actual)

Groups and cohorts

  • Chronic Graft-Versus Host Disease (GvHD)

    Participants with chronic graft-versus host disease (GvHD)

    Behavioral: Questionnaire

Interventions

  • BehavioralQuestionnaire

    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

06

Study locations

2 sites
  • U.T.M.D. Anderson Cancer Center
    Houston, Texas 77030, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
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References and documents

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00506233
Responsible party
Sponsor
First posted
Jul 25, 2007
Start date
Aug 2006
Primary completion
Sep 2007
Last update
Jul 31, 2012

Study contacts

Amin Alousi, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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