Blood Stem Cell Transplant FailureNCT01135355
Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients
An observational study of Blood Stem Cell Transplant Failure, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Blood Stem Cell Transplant Failure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2011
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Hematopoietic stem cell transplantation (HSCT) for any indication.
Inclusion Criteria:- Hematopoietic stem cell transplantation (HSCT) for any indication.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients at Risk for Respiratory Failure
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.
- Conditions
- Blood Stem Cell Transplant Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Compute median flourescence intensity, standard curves, and estimated pg/mL for each cytokine.
Measured: weekly during hospitalization for transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionJan 2011
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 Stanford UniversityThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajni Agarwal, Stanford University
- Investigators
- Rajni Agarwal-Hashmi, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135355
- Sponsor's protocol ID
- PEDSBMT199
- Other IDs
- SU-09222008-1301, PEDSHSCT0002, 14862
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2010
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Assay for Early Identification of Pediatric Stem Cell Transplant Recipients at Risk for Respiratory Failure
- ClinicalTrials.gov ID
- NCT01135355
- Acronym / sponsor ID
- PEDSBMT199
- Conditions
- Blood Stem Cell Transplant Failure
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 Jun 2010 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Hematopoietic stem cell transplantation (HSCT) for any indication.
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
Compute median flourescence intensity, standard curves, and estimated pg/mL for each cytokine.
Time frame: weekly during hospitalization for transplant
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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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.
Rajni Agarwal-Hashmi principal investigator
Stanford University
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 Stanford University 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?
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: stopped early, as of the sponsor's last update on 21 Jun 2024. 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 stopped early. Results are not available in the source record.
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?
Compute median flourescence intensity, standard curves, and estimated pg/mL for each cytokine. (time frame: weekly during hospitalization for transplant). 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 21 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.