Text Size

Analysis of Biomarkers for Acute Graft-versus-Host Disease (GVHD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mark R. Litzow, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01569373
First received: March 29, 2012
Last updated: April 25, 2013
Last verified: April 2012
History of Changes
  Purpose

Samples of blood and urine will be analyzed for biomarkers to check their predictivity of Graft-versus-Host Disease (GVHD) outcomes.


Condition
Blood Stem Cell Transplant Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Biomarkers for Acute Graft-versus-Host Disease (GVHD).

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Diagnosis of severe acute GVHD [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Post allogeneic SCT patients
Patients who have undergone an allogeneic stem cell transplant.

Detailed Description:

To determine if serum biomarkers of inflammation correlate with onset and severity of acute GVHD, particularly GVHD of the gut.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have undergone an allogeneic stem cell transplant being followed for post transplant care.

Criteria

Inclusion Criteria:

  • 18 years old or older patients
  • Undergoing allogeneic stem cell transplant

Exclusion Criteria:

None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569373

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Litzow, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Mark R. Litzow, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01569373     History of Changes
Other Study ID Numbers: 12-001493
Study First Received: March 29, 2012
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Allogeneic stem cell transplant
Graft versus Host Disease
GVHD

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013