Clinical trial NCT01688752: Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia
Official title: Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiometabolic Profile
timeFrame: up to 2.5-3 Years
Secondary outcomes:
measure: Prevalence of Blunted Stimulated Growth Hormone Response
timeFrame: Between 2.5 and 3 Years
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Julia Steinberger, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: