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Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00578409
Collaborator
Aureon Biosciences, Inc. (Industry), NYU MEDICAL CENTER (Other)
758
Enrollment
1
Location
71
Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We seek to improve the predictive accuracy of the nomogram to predict survival for patients with castrate mets disease through the addition of pathological data, the results of automated machine vision based image analysis of H&E stained tumor tissue developed at Aureon Biosciences,and molecular biomarker studies (25 markers) determined by immunohistochemistry on tissue microarrays prepared from paraffin-embedded tumor.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    758 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data
    Study Start Date :
    May 1, 2004
    Actual Primary Completion Date :
    Apr 1, 2010
    Actual Study Completion Date :
    Apr 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. The analysis for the progressive castrate mets disease population consists of two analytical steps. The first step involved the development of a predictive model of pt survival using supervised multivariate analytical (SMA)techniques [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients in the first retrospective study (Stage 1) must be part of the 409 patient strong MSKCC cohort with progressive metastatic prostate cancer which was used for the generation of the original nomogram.

    For details please see original publication by Smaletz et al. Patients involved in the second retrospective study (Stage 2) must be part of the 223 patients with a rising PSA after surgery or radiation therapy who were treated on conjugate vaccine trials at MSKCC..

    Exclusion Criteria:

    For details of excluded patients on the clinical metastases castrate disease study, please see original publication by Smaletz et al.4

    • (MSKCC - add reference if publication available for rising PSA patients)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • Aureon Biosciences, Inc.
    • NYU MEDICAL CENTER

    Investigators

    • Principal Investigator: Howard I Scher, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00578409
    Other Study ID Numbers:
    • 04-062
    First Posted:
    Dec 21, 2007
    Last Update Posted:
    Dec 18, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Memorial Sloan Kettering Cancer Center
    castration resistant prostate cancer
    progressive castrate metastatic prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Dec 18, 2015