Graft-Versus-Host DiseaseNCT00600314
Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease
An observational study of Graft-Versus-Host Disease, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations. Read more about this study
- Who is it for?
- Ages 7 to 30 years
- Conditions the study is for
- Graft-Versus-Host Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Sep 2010
- 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 7 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: High risk population: patients who are at high risk of developing acute or chronic Graft versus Host Disease (GVHD) following an allogeneic transplant. GVHD population: patients with active GHVD, either acute or chronic
Who may be able to join
- Subjects must be 7-30 years of age
- Signed informed consent
- One of the following three criteria must be met:
- Presence of grade II or greater acute GVHD as defined by Keystone criteria
- Presence of clinically extensive chronic GVHD as defined by the revised Seattle criteria
- Any subject identified prior to allogeneic transplant, or following allogeneic transplant, who is at risk for acute or chronic GVHD
Who cannot join
- Inability to meet the requirements of the study procedures
- Any subject who is receiving supplemental oxygen
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hospital
Chicago, Illinois, 60614-3363
About this study
This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations.
Read the detailed description
Chronic Graft versus Host Disease (GVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow and hematopoietic progenitor cell transplantation. In adults, it has been shown that patients with acute or chronic GVHD have an increase in their resting energy expenditure (REE), likely as a result of chronic systemic inflammation. These studies have not yet been performed in children. This study's objective is to determine the REE of pediatric patients with acute and chronic GVHD after hematopoietic stem cell transplantation (HSCT).
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Graft-Versus-Host Disease, Transplantation, Allogeneic, Transplantation, Hematopoietic Stem Cell, Calorimetry, Respiration
- Medical subject headings
- Graft vs Host Disease, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High risk | Patients who are at high risk of developing acute or chronic GVHD | |
| GVHD | Patients who currently have either grade II or greater acute GVHD, or clinically extensive chronic GVHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - can the procedure be adequately performed in a child?
Measured: Spring of 2010
Secondary outcomes (1)
Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min)
Measured: Spring of 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startApr 2005
- Primary completionSep 2010
- Study completionSep 2010
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.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morris Kletzel, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600314
- Sponsor's protocol ID
- SCT 0405 REE
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2008
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT00600314
- Acronym / sponsor ID
- SCT 0405 REE
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Graft-Versus-Host Disease, Transplantation, Allogeneic, Transplantation, Hematopoietic Stem Cell, Calorimetry, Respiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Jan 2008 (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.
This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations.
Detailed description
Chronic Graft versus Host Disease (GVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow and hematopoietic progenitor cell transplantation. In adults, it has been shown that patients with acute or chronic GVHD have an increase in their resting energy expenditure (REE), likely as a result of chronic systemic inflammation. These studies have not yet been performed in children. This study's objective is to determine the REE of pediatric patients with acute and chronic GVHD after hematopoietic stem cell transplantation (HSCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk | – | –Patients who are at high risk of developing acute or chronic GVHD |
| GVHD | – | –Patients who currently have either grade II or greater acute GVHD, or clinically extensive chronic GVHD |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- High risk population: patients who are at high risk of developing acute or chronic Graft versus Host Disease (GVHD) following an allogeneic transplant. GVHD population: patients with active GHVD, either acute or chronic
Key inclusion criteria (6 listed)
- Subjects must be 7-30 years of age
- Signed informed consent
- One of the following three criteria must be met:
Key exclusion criteria (3 listed)
- Inability to meet the requirements of the study procedures
- Any subject who is receiving supplemental oxygen
- Withdrawal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility - can the procedure be adequately performed in a child?
Time frame: Spring of 2010
1 secondary outcome
Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min)
Time frame: Spring of 2012
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 28 Jan 2025.
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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.
Morris Kletzel, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site 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 Ann & Robert H Lurie Children's Hospital of Chicago at 1 site 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 6 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Feasibility - can the procedure be adequately performed in a child? (time frame: Spring of 2010). It is what the study was designed to measure, not a finding.
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 28 Jan 2025.