Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia



Status:Completed
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:December 2012
End Date:October 2015
Contact:Julia Steinberger, MD, MS
Email:stein055@umn.edu
Phone:612-626-2755

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Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study


This is a prospective cohort study assessing measures of cardiometabolic status, body
composition, IR and GH response to stimulation after therapy in children (age 7-21 years)
treated for ALL. Patients and sibling controls will be recruited from the Pediatric
Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.


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.
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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mi
from
Minneapolis, MN
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