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: May 2, 2014
Last verified: May 2014
  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).

Resource links provided by NLM:


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 2017
Estimated Primary Completion Date: March 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 2, 2014
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 August 26, 2014