Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia

Withdrawn

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT01688752
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-20
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiometabolic Profile	up to 2.5-3 Years	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Blunted Stimulated Growth Hormone Response	Between 2.5 and 3 Years	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.