- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00899184
DNA Changes in Patients With Prostate Cancer
Assessment of SNP Genotypes in Men With Prostate Cancer
RATIONALE: Collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers with prostate cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients with prostate cancer, their affected siblings, and an unaffected healthy population (control).
- Determine the age of onset of prostate cancer in affected probands and affected siblings.
- Determine the penetrance or likelihood that given SNPs will result in disease in affected siblings based upon Mendelian genetics.
- Determine the odds ratio of developing prostate cancer in the presence of SNPs.
- Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or androgen-ablation therapy with chemotherapy, and correlate them with disease progression (i.e., androgen independence).
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to ethnicity, age at diagnosis, and Gleason score.
Patients, their affected siblings, and healthy participants (controls) undergo collection of blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and biographical data.
PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy participants (controls) will be accrued for this study.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
- Patient or sibling diagnosed with prostate cancer
- Cancer-free participant (healthy control)
- Whole blood sample available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Frequency of single nucleotide polymorphism (SNP) genotypes
Tidsramme: 1 month
|
1 month
|
|
Age of onset of prostate cancer in patients and their affected siblings
Tidsramme: 1 month
|
1 month
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Kim M. Hirshfield, MD, PhD, Rutgers Cancer Institute of New Jersey
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
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
- CDR0000492784
- ECOG-E1Y97T1
- ECOG-O00PCONS01
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