Graft-Versus-Host DiseaseNCT02194439
Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease
An observational study of Graft-Versus-Host Disease, run by Indiana University at 1 site in United States.
Trial summary
This study is designed to collect longitudinal biological samples from patients after hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers to validate biomarkers of both acute and chronic GVHD as well as for use in future unspecified research. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft-Versus-Host Disease
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 30 Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) from Dana-Farber Cancer Institute and Boston Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and Indiana University Simon Cancer Center
Inclusion Criteria: - All patients receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) can be included.
Exclusion Criteria: - patients not receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Unversity Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
This study is designed to collect longitudinal biological samples from patients after hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers to validate biomarkers of both acute and chronic GVHD as well as for use in future unspecified research. The centers include Dana-Farber Cancer Institute and Boston's Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and Indiana University Simon Cancer Center.
Read the detailed description
After informed consent is signed, this study will involve 1) collection of basic HCT data and clinical data available in the medical record and 2) providing blood (and saliva in occasional cases) samples for processing, storage, DNA extraction, and analysis (including a seven biomarker protein panel as well as future unspecified research purposes).
Pediatric and adult patients will be included (all adult patients will be from the Fred Hutchinson Cancer Research Center, the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and the Indiana University Simon Cancer Center).
Primary Objective:
- To confirm that ST2 alone or the seven-biomarker panel measured at initiation of GVHD therapy predict a) D180 post-therapy non-relapse mortality; b) D28 post-therapy non-response, and c) GVHD grade 1-4 onset D180 post-therapy non-relapse mortality.
Secondary Objective:
- To demonstrate that ST2 alone or the seven-biomarker panel measured at day 14 or day 21 post-HCT (or a combination of these time points) predicts D180 post-HCT non-relapse mortality.
- To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy diagnose acute GVHD as compared to other complications presenting with similar symptoms (drug rash, CMV, Clostridium enteritis).
- To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy diagnose the severity of acute GVHD at onset and maximum.
- To develop a repository of biospecimens linked to clinical data for future unspecified research.
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Acute Graft Versus Host Disease, Affect, Anti-inflammatory, Anti-inflammatory Agents, Antigen-Presenting Cells, Alloantigen, Allogeneic, Allograft rejection, Allograft Tolerance, Antigens, Autoimmunity, Biomarkers, Biospecimen Repository, BMT, Bone Marrow Transplantation, Cell Transplantation, Cells, Clonal Expansion, Complex, Cytokine
- Medical subject headings
- Graft vs Host Disease, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hematopoietic stem cell transplant | procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJan 2014
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana 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
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sophie Paczesny, Indiana University
- Investigators
- Sophie Paczesny, MD, PhD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194439
- Sponsor's protocol ID
- 1405976232
- Other IDs
- 1R01HD074587-01
- Status last verified
- Feb 2021
- First submitted
- 11 Jul 2014
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rowan CM, Pike F, Cooke KR, Krance R, Carpenter PA, Duncan C, Jacobsohn DA, Bollard CM, Cruz CRY, Malatpure A, Farag SS, Renbarger J, Liu H, Bakoyannis G, Hanash S, Paczesny S. Assessment of ST2 for risk of death following graft-versus-host disease in pediatric and adult age groups. Blood. 2020 Apr 23;135(17):1428-1437. doi: 10.1182/blood.2019002334.
PubMed 31972009
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT02194439
- Acronym / sponsor ID
- 1405976232
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Acute Graft Versus Host Disease, Affect, Anti-inflammatory, Anti-inflammatory Agents, Antigen-Presenting Cells, Alloantigen, Allogeneic, Allograft rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2014 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Posted 26 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to collect longitudinal biological samples from patients after hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers to validate biomarkers of both acute and chronic GVHD as well as for use in future unspecified research. The centers include Dana-Farber Cancer Institute and Boston's Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and Indiana University Simon Cancer Center.
Detailed description
After informed consent is signed, this study will involve 1) collection of basic HCT data and clinical data available in the medical record and 2) providing blood (and saliva in occasional cases) samples for processing, storage, DNA extraction, and analysis (including a seven biomarker protein panel as well as future unspecified research purposes).
Pediatric and adult patients will be included (all adult patients will be from the Fred Hutchinson Cancer Research Center, the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and the Indiana University Simon Cancer Center).
Primary Objective:
- To confirm that ST2 alone or the seven-biomarker panel measured at initiation of GVHD therapy predict a) D180 post-therapy non-relapse mortality; b) D28 post-therapy non-response, and c) GVHD grade 1-4 onset D180 post-therapy non-relapse mortality.
Secondary Objective:
- To demonstrate that ST2 alone or the seven-biomarker panel measured at day 14 or day 21 post-HCT (or a combination of these time points) predicts D180 post-HCT non-relapse mortality.
- To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy diagnose acute GVHD as compared to other complications presenting with similar symptoms (drug rash, CMV, Clostridium enteritis).
- To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of GVHD symptoms/therapy diagnose the severity of acute GVHD at onset and maximum.
- To develop a repository of biospecimens linked to clinical data for future unspecified research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hematopoietic stem cell transplant | – | –procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor cellular infusion (DCI) from Dana-Farber Cancer Institute and Boston Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and Indiana University Simon Cancer Center
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
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
Time frame: 1 year
To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31972009Rowan CM, Pike F, Cooke KR, Krance R, Carpenter PA, Duncan C, Jacobsohn DA, Bollard CM, Cruz CRY, Malatpure A, Farag SS, Renbarger J, Liu H, Bakoyannis G, Hanash S, Paczesny S. Assessment of ST2 for risk of death following graft-versus-host disease in pediatric and adult age groups. Blood. 2020 Apr 23;135(17):1428-1437. doi: 10.1182/blood.2019002334.
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Graft vs Host Disease
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.
Sophie Paczesny, MD, PhD study chair
Indiana 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 Graft-Versus-Host Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02194439, which also lists 1 linked publication.
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 26 Feb 2021.