Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Withdrawn

Conditions

Acute Lymphoblastic Leukemia

Study type

Observational

Funder types

Other

Identifiers

NCT01688752
2012NTLS086

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

7 to 21 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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