Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study
7 Years
21 Years
Both
Acute Lymphoblastic Leukemia
Trial Information
Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study
This is a prospective cohort study with two groups: survivors of acute lymphoblastic
leukemia (ALL) who have recently completed therapy (cases) and healthy siblings (controls)
frequency matched by age and sex. Subjects in each group will have two visits. For cases,
the first visit will be approximately 6 months after completion of treatment for ALL; for
their siblings, the first visit occur at approximately the same time. For both cases and
controls, the second visit will be 2 to 2.5 years after the first visit.
Inclusion Criteria:
- Patients
- Age 7 years to less than or equal to 21 years at time of study enrollment.
- Acute lymphoblastic leukemia (ALL) as first cancer diagnosis and in first
complete remission. Any subtype is eligible.
- Study enrollment must take place at/after six months of completion of all
chemotherapy.
- Patients must have a performance status corresponding to Eastern Cooperative
Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16
years of age and Lansky for patients ≤ 16 years of age.
- Any prior ALL therapy is allowable.
- Siblings
- Age 7 years to less than or equal to 21 years at time of study enrollment.
- Sibling of ALL patient.
Exclusion Criteria:
- Patients
- Diagnosis of diabetes mellitus prior to ALL diagnosis or at time of study
enrollment.
- Current pregnancy
- Prior hematopoietic cell transplant.
- Receiving growth hormone replacement or corticosteroids at the time of
enrollment.
- Siblings
- Previously diagnosed with malignancy.
- Diagnosis of diabetes mellitus.
- Current pregnancy
- Receiving growth hormone replacement or corticosteroids at the time of
enrollment.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Cardiometabolic Profile
Outcome Description:
To determine the cardiometabolic profile (as measured by a single score based on adiposity, serum lipids, and vascular function) shortly after therapy (6 months after completion of therapy [Visit 1]) and again 2.5-3 yrs after completion of therapy (Visit 2) in 300 ALL patients, and compare with 200 sibling controls.
Outcome Time Frame:
up to 2.5-3 Years
Safety Issue:
No
Principal Investigator
Julia Steinberger, MD, MS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Institutional Review Board
Study ID:
2012NTLS086
NCT ID:
NCT01688752
Start Date:
Completion Date:
Related Keywords:
- Acute Lymphoblastic Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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