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Clinical Trials/NCT01402154
NCT01402154
Unknown
Not Applicable

The Pre-treatment Detection of Circulating, Functional, Prostate Cells Among Adenocarcinoma Patients: an Evaluation of the EPISPOT Technique

Centre Hospitalier Universitaire de Nīmes5 sites in 1 country361 target enrollmentJanuary 3, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adenocarcinoma of the Prostate
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
361
Locations
5
Primary Endpoint
The difference between AUCs for the EPISPOT and Cellsearch Techniques
Last Updated
4 years ago

Overview

Brief Summary

The primary objective of this study is to evaluate the predictive value (in terms of remission) of a new technique for detecting circulating, functional, prostate cells among patients with localized adenocarcinoma of the prostate, and prior to any treatment.

Registry
clinicaltrials.gov
Start Date
January 3, 2012
End Date
December 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • Histologically proven presence of prostate adenocarcinoma
  • Localized disease on digital rectal examination
  • Cancer without extensions
  • Acceptance of a curative treatment by the patient

Exclusion Criteria

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is taking a hormone-modifying treatment
  • Patient taking adrogenic supplements

Outcomes

Primary Outcomes

The difference between AUCs for the EPISPOT and Cellsearch Techniques

Time Frame: 1 day

The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells

Study Sites (5)

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