NCT01569373

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

5.6 years

First QC Date

March 29, 2012

Last Update Submit

September 27, 2023

Conditions

Blood Stem Cell Transplant Failure

Keywords

Allogeneic stem cell transplantGraft versus Host DiseaseGVHD

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of severe acute GVHD

    2 months

Study Arms (1)

Post allogeneic SCT patients

Patients who have undergone an allogeneic stem cell transplant.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Mark Litzow, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 3, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

US(1)