Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Lymphoblastic Leukemia

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sibling Controls; Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex.
Acute Lymphoblastic Leukemia Survivors; Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2.5-3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between 2.5 and 3 Years

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 20, 2012

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: 2012NTLS086