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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00636090 |
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Date of registration:
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09/03/2008 |
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Primary sponsor: |
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Public title:
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Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001
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Scientific title:
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Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001 |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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60 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00636090 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel J George, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must be enrolled in the clinical study entitled: A Single Arm, Phase II
Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer at
the time of enrollment onto this study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Metastatic Hormone Refractory Prostate Cancer
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Primary Outcome(s)
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Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001.
[Time Frame: pre-treatment, day 29, and monthly blood samples]
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Secondary Outcome(s)
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To determine by comparative genomic hybridation (CGH) loss of heterozygosity (LOH) patterns of the 10q23 locus (to assess PTEN status) and other sites of chromosomal alterations associated with pathologic response to mTOR inhibition.
[Time Frame: pre-treatment, day 19, and monthly blood samples]
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To identify candidate plasma markers of glycolysis that reflect tumor AKT activity.
[Time Frame: pre-treatment, day 29, and monthly blood samples]
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To identify expression profiles associated with AKT activation and RAD001 treatment effect.
[Time Frame: pre-treatment, day 29, and monthly blood samples]
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Secondary ID(s)
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CA123175
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DUMC-0346
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R01-A2-022207
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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