Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia

NCT ID: NCT01688752

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL

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.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Sibling Controls

Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex.

No interventions assigned to this group

Acute Lymphoblastic Leukemia Survivors

Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy.

No interventions assigned to this group

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Steinberger, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Other Identifiers

2012NTLS086

Identifier Type: -

Identifier Source: org_study_id