Biomarkers of endothelial dysfunction in pediatric patients receiving high intensity chemotherapy/irradiation
Study on Blood Sample Collection in Patients Undergoing Stem Cell Transplantation
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: stem cell transplant,stem cell,chemotherapy,irradiation,cancer,oncology,pediatric,riley,kid,kids,child,children,teen,teens,teenager,teenagers,adolescent,youth
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Age: 18 years or below
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Gender: All
Age ? 18 years undergoing HCT for any reason who fulfill any ONE (1) of the following criteria:
History of hepatic disease as defined by:
a. Viral hepatitis (i.e., hepatitis C virus [HCV])
b. Liver tumor before HCT
c. Hepatic fibrosis or cirrhosis before HCT as proven by liver biopsy
d. High aspartate aminotransferase (AST) (> 2x ULN) before HCT (pre-transplant evaluation)
e. High alanine transaminase (ALT) (> 2x ULN) before HCT
f. High bilirubin (> 1.2x ULN) before HCT
HCT high-risk features including:
a. Conditioning with high-risk modalities including:
i. Busulfan (BU)-containing regimen particularly with oral BU + cyclophosphamide
ii. TBI-containing regimen, particularly cyclophosphamide + total-body irradiation (TBI)
b. greater that of equal to 2 HCT
c. Allo-HCT for leukemia > or = second relapse
d. Unrelated donor (URD) HCT
e. Human leukocyte antigen (HLA) mismatch HCT (less than 10 of 10 for bone marrow/peripheral blood stem cell [BM/PBSC] or anything less than 6 of 6 for UCB)
f. Use of sirolimus + tacrolimus prophylaxis for GVHD
High-risk disease states including:
a. Juvenile myelo-monocytic chronic leukemia (JMML)
b. Primary hemophagocytic lymphohistiocytosis (HLH)
c. Adrenoleukodystrophy
d. Osteopetrosis
Other high-risk features including:
a. Prior treatment with gemtuzumab ozogamicin
b. Use of hepatotoxic drugs 1 month before HCT and during HCT
c. Iron overload (i.e., thalassemia/sickle cell) with serum ferritin > 1000ng/ml
d. Deficit of ATIII, T-PA (i.e., 30% normal values), and resistance to activated protein C if clinical indication (these values do not have to be specifically checked if no clinical history)
e. Young age 2 years but more than 1 month
Exclusion Criteria
Patients who are transplanted but do not fulfill any of the above mentioned criteria
The purpose of this study is to collect blood specimens and data from patients undergoing a stem cell transplant. Stem cell transplants are procedures where patients receive blood-forming stem cells to replace damaged or diseased bone marrow. This study aims to gather information from patients who have certain conditions or treatments related to their transplant.
Participants in this study will have blood samples collected and data recorded as part of their regular medical care. These procedures are done to monitor health and treatment progress. The study will include various tests and evaluations to ensure comprehensive data collection.
- Who can participate: Adults aged 18 and older undergoing a stem cell transplant may participate. Eligibility includes a history of liver disease, high-risk transplant features, or certain high-risk diseases. Key factors are specific liver conditions, high-risk transplant regimens, and certain blood or genetic disorders.
- Study details: Participants will provide blood samples and medical data as part of their regular care.
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