- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
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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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Todd E. Druley, MD, St. Louis Children's Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AALL10B2
- COG-AALL10B2 (Annan identifierare: Children's Oncology Group)
- CDR0000672526 (Annan identifierare: Clinicaltrials.gov)
- NCI-2011-02232 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
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