Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia
21. august 2014 opdateret af: 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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
7 år til 21 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cardiometabolic Profile
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of Blunted Stimulated Growth Hormone Response
Tidsramme: Between 2.5 and 3 Years
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Datoer for studieregistrering
Først indsendt
17. september 2012
Først indsendt, der opfyldte QC-kriterier
19. september 2012
Først opslået (Skøn)
20. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012NTLS086
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