Graft-Versus-Host DiseaseNCT00506233
Feasibility Study of Collecting Multicenter Chronic GVHD Data
An observational study of Graft-Versus-Host Disease, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with chronic graft-versus host disease (GvHD) at UT MD Anderson Cancer Center.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Primary Objective:
- 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.
- Conditions
- Graft-Versus-Host Disease
- Being tested
- Questionnaire
- Keywords
- Graft-Versus-Host Disease, GVHD, Questionnaire
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Graft-Versus Host Disease (GvHD) | Participants with chronic graft-versus host disease (GvHD) Receives: Behavioral: Questionnaire |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startAug 2006
- Primary completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amin Alousi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506233
- Sponsor's protocol ID
- 2006-0541
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2007
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Collecting Multicenter Chronic GVHD Data
- ClinicalTrials.gov ID
- NCT00506233
- Acronym / sponsor ID
- 2006-0541
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Graft-Versus-Host Disease, GVHD, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Sep 2007 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To determine the feasibility of conducting a multi-site longitudinal observational study of patients with chronic graft-versus-host disease (GVHD).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Graft-Versus Host Disease (GvHD) | – | Behavioral: QuestionnaireParticipants with chronic graft-versus host disease (GvHD) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with chronic graft-versus host disease (GvHD) at UT MD Anderson Cancer Center.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: surveysCompletion 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. | Behavioural | Chronic Graft-Versus Host Disease (GvHD) |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Graft-Versus-Host Disease
Active, not recruitingObservational study
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Bone Marrow Transplant Complications
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Active, not recruitingEarly Phase 1
Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide
Chronic Granulomatous Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amin Alousi, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft-Versus-Host Disease, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.