- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01119586
Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia
Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing
RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children and matched non-tumor and blast DNA from patients with high-risk (HR) acute lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols.
- To identify loci enriched for genetic variation between DNA of unaffected children and DNA of these patients.
- To individually validate novel, putatively functional single nucleotide polymorphisms (SNPs) identified via pooled sequencing with another genotyping platform.
- To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation.
OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3 PCR pools of DNA.
Studietype
Registrering (Forventet)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
DISEASE CHARACTERISTICS:
Newly diagnosed with high-risk B-precursor acute lymphoblastic leukemia
- Matched patients non-tumor and blast DNA samples
- Enrolled on COG-P9906 or COG-AALL0232 protocols
- Cohort of random pediatric DNA samples extracted from newborn infants' blood spots from the State of Missouri
PATIENT CHARACTERISTICS:
- Newborn infants from the state of Missouri
PRIOR CONCURRENT THERAPY:
- Not specified
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
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Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis
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Correlation between high-risk acute lymphoblastic leukemia with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Todd E. Druley, MD, St. Louis Children's Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AALL10B2
- COG-AALL10B2 (Annen identifikator: Children's Oncology Group)
- CDR0000672526 (Annen identifikator: Clinicaltrials.gov)
- NCI-2011-02232 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
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