NCT01135355

Brief Summary

The aim of our study is to determine whether a clinically relevant laboratory measurement (of seven specific immunologic biochemicals in the blood) can identify which bone marrow transplant recipients are likely to progress to respiratory failure. Our ultimate goal is to devise a comprehensive and inclusive laboratory test that is effective at determining who is likely to go on to respiratory failure, in order to facilitate early medical intervention.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

2.4 years

First QC Date

June 1, 2010

Last Update Submit

June 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compute median flourescence intensity, standard curves, and estimated pg/mL for each cytokine.

    weekly during hospitalization for transplant

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Hematopoietic stem cell transplantation (HSCT) for any indication.

You may qualify if:

  • Patients will range from age 0 to age 21. There is no gender restriction. We expect the male to female ratio to end up being about 50/50
  • Ability to understand and the willingness to sign a written informed consent document.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

Study Officials

  • Rajni Agarwal-Hashmi

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 2, 2010

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations