Clinical trial · Observational
Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia
Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study
NCT01688752CI-TRIAL-00015462withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Sibling Controls
- description
- Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex.
- label
- Acute Lymphoblastic Leukemia Survivors
- description
- Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy.
Primary outcomes (1)
- measure
- Cardiometabolic Profile
- timeFrame
- up to 2.5-3 Years
- description
- 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 outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.