Blood Stem Cell Transplant FailureNCT01569373
Analysis of Biomarkers for Acute Graft-versus-Host Disease (GVHD)
An observational study of Blood Stem Cell Transplant Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
Samples of blood and urine will be analyzed for biomarkers to check their predictivity of Graft-versus-Host Disease (GVHD) outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Stem Cell Transplant Failure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone an allogeneic stem cell transplant being followed for post transplant care.
Who may be able to join
- 18 years old or older patients
- Undergoing allogeneic stem cell transplant
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Biomarkers for Acute Graft-versus-Host Disease (GVHD).
Samples of blood and urine will be analyzed for biomarkers to check their predictivity of Graft-versus-Host Disease (GVHD) outcomes.
Read the detailed description
To determine if serum biomarkers of inflammation correlate with onset and severity of acute GVHD, particularly GVHD of the gut.
- Conditions
- Blood Stem Cell Transplant Failure
- Keywords
- Allogeneic stem cell transplant, Graft versus Host Disease, GVHD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Post allogeneic SCT patients | Patients who have undergone an allogeneic stem cell transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of severe acute GVHD
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: Resources needed to complete the study were not able to be obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stem Cell Transplant FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark R. Litzow, Mayo Clinic
- Investigators
- Mark Litzow, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569373
- Sponsor's protocol ID
- 12-001493
- Status last verified
- Sep 2023
- First submitted
- 29 Mar 2012
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Biomarkers for Acute Graft-versus-Host Disease (GVHD).
- ClinicalTrials.gov ID
- NCT01569373
- Acronym / sponsor ID
- 12-001493
- Conditions
- Blood Stem Cell Transplant Failure
- Keywords
- Allogeneic stem cell transplant, Graft versus Host Disease, GVHD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Resources needed to complete the study were not able to be obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 3 Apr 2012 (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.
Samples of blood and urine will be analyzed for biomarkers to check their predictivity of Graft-versus-Host Disease (GVHD) outcomes.
Detailed description
To determine if serum biomarkers of inflammation correlate with onset and severity of acute GVHD, particularly GVHD of the gut.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post allogeneic SCT patients | – | –Patients who have undergone an allogeneic stem cell transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone an allogeneic stem cell transplant being followed for post transplant care.
Key inclusion criteria (2 listed)
- 18 years old or older patients
- Undergoing allogeneic stem cell transplant
Key exclusion criteria (1 listed)
- None
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
Diagnosis of severe acute GVHD
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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.
Mark Litzow, MD principal investigator
Mayo Clinic
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 Blood Stem Cell Transplant Failure, run by Mayo Clinic 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Sep 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Diagnosis of severe acute GVHD (time frame: 2 months). 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 29 Sep 2023.