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

NCT ID: NCT00578409

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

758 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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castration resistant prostate cancer progressive castrate metastatic prostate cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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)
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Aureon Biosciences, Inc.

INDUSTRY

Sponsor Role collaborator

NYU MEDICAL CENTER

UNKNOWN

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard I Scher, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan-Kettering Web Site

Other Identifiers

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04-062

Identifier Type: -

Identifier Source: org_study_id