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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD074587-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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:
1. 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hematopoietic stem cell transplant | procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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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.
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Paczesny, MD, PhD | Indiana University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Unversity Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31972009 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hematopoietic Stem Cell Transplant | 4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients who performed biomarker collection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hematopoietic Stem Cell Transplant | 4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who had all four biomarkers and four timepoints. | Posted | Number | participants | 1 year |
|
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up to 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hematopoietic Stem Cell Transplant | 4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sophie Paczesny | IndianaU | 317-278-5487 | sophpacz@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2020 | Feb 6, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 12, 2015 | Feb 6, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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Whole Blood, Plasma, Peripheral Blood Mononuclear Cells (PBMC), Saliva, Bronchoalveolar lavage (BAL)
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| 0 |
| 415 |
| 0 |
| 415 |
| 0 |
| 415 |
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