An observational study in Acute Lymphoblastic Leukemia, sponsored by University of Minnesota. Withdrawn. Open to participants aged 7 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-22.
Sponsored by University of Minnesota · Observational
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.
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Study entry is open to patients regardless of gender or ethnic background. While there will be every effort to seek out and include females and minority patients, the patient population is expected to be no different than the general pediatric oncology population seen at the participating institutions.
Patients
Siblings
Exclusion Criteria:
Patients
Siblings
Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex.
Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy.
Cardiometabolic Profile
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.
Time frame: up to 2.5-3 Years
Prevalence of Blunted Stimulated Growth Hormone Response
To determine the prevalence of blunted stimulated GH response suggesting GH deficiency (peak GH \<7mcg/L) in ALL survivors and controls: GH level will be obtained at baseline, then +30, +60, +90 and +120 minutes after clonidine (5 mcg/kg up to 200 mcg by mouth), followed by infusion of arginine (0.5 grams/kg up to 30 grams) with a series of GH levels at +140, +160, +180, +210, and +240 minutes. Blunted response to GH stimulation will be defined as peak GH level\<7 mcg/L.
Time frame: Between 2.5 and 3 Years
No study locations are listed for this record.
This study is withdrawn, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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University of Minnesota