Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia
21 augusti 2014 uppdaterad av: University of Minnesota
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.
Studieöversikt
Status
Indragen
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
7 år till 21 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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Sibling Controls
Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex.
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Acute Lymphoblastic Leukemia Survivors
Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Cardiometabolic Profile
Tidsram: up to 2.5-3 Years
|
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.
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up to 2.5-3 Years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Prevalence of Blunted Stimulated Growth Hormone Response
Tidsram: Between 2.5 and 3 Years
|
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.
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Between 2.5 and 3 Years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studieregistreringsdatum
Först inskickad
17 september 2012
Först inskickad som uppfyllde QC-kriterierna
19 september 2012
Första postat (Uppskatta)
20 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 augusti 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 augusti 2014
Senast verifierad
1 augusti 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2012NTLS086
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