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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-11324 | Other Identifier | NCI-CTRP Clinical Trials Reporting Registry |
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This is a prospective international multi-center registry and biorepository trial of children and adolescents/young adults (AYA) undergoing hematopoietic cell transplantation (HCT) to assess the impact of endotheliopathies in the HCT setting as a contributor of significant morbidity and mortality.
Primary:
Secondary/Exploratory Objective(s):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biorepository trial of children and adolescents/young adults (AYA) | undergoing hematopoietic cell transplantation (HCT) to assess the impact of endotheliopathies in the HCT setting as a contributor of significant morbidity and mortality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biorepository Trial | Other | participating in this arm, peripheral blood specimen(s) will be obtained at 8 specified time-points. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of pediatric patients undergoing hematopoietic cell transplant (HCT) who develop endotheliopathies (SOS, TMA, DAH and IPS) and/or MODS within 100 days of such therapies. | through study completion, an average of 1 year | |
| Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of circulating angiogenic factors within 100 days post HCT-CT in the setting of endotheliopathies. | through study completion, an average of 1 year | |
| Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of vascular permeability within 100 days post HCT-CT in the setting of endotheliopathies. | through study completion, an average of 1 year | |
| Proportion of pediatric patients undergoing (HCT) who experience abnormal levels of inflammatory factors within 100 days post HCT-CT in the setting of endotheliopathies. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Children, adolescents and young adults (AYA) 0-26 years of age undergoing HSCT.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LaTarsha Spencer | Contact | (919) 613-1895 | latarsha.spencer@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kris Mahadeo | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55902 | United States |
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| Label | URL |
|---|---|
| Duke University Medical Center | View source |
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| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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