- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01066338
Genome-wide Pharmacogenetic Candidate Gene Single Nucleotide Polymorphism (SNP) Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype
Genome-wide Pharmacogenetic Candidate Gene SNP Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype
The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by karyotyping. According to cytogenetic results, the patients with AML are classified as better, intermediate and poor prognosis groups. The normal karyotype AML was reported in about 50% of all AML and classified as intermediate risk group. However, the patients with normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup analysis of normal karyotype AML are needed. Recently, the understandings of human genome polypmorphism using SNP array have been accumulated. However, the advanced researches for clinical application are not enough.
The study design is a retrospective and single-center study. The patients with normal karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea) will be enrolled. The stored bone marrow samples of enrolled patients are used for genome wide scanning by SNP array.
The purpose of present study is to develop predictive pharmacogenemic biomarkers model associated wit clinical outcomes including efficacy and toxicity in patients with AML with normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to develop enrichment clinical trial based on predictive pharmacogenomic model.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken, 135-710
- Rekruttering
- Samsung Medical Center
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Ta kontakt med:
- Dong Hwan Kim, M.D., Ph. D.
- Telefonnummer: +82-2-3410-1768
- E-post: dr.dennis.kim@samsung.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- patients with normal karyotype acute myeloid leukemia
- 18 years or older
- patients were treated with standard chemotherapy
- patients with available medical record and stored bone marrow specimen at time of diagnosis
Exclusion Criteria:
- no definitive criteria
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Normal karyotype
The patients were diagnosed as acute myeloid leukemia with normal karyotype.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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overall response rate
Tidsramme: within 1 month after enrollment
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within 1 month after enrollment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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overall survival time
Tidsramme: within 1 month after enrollment
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within 1 month after enrollment
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
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
- 2009-10-070
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