EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

August 4, 2021 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

361

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34070
        • Clinique Beau Soleil
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque
      • Montpellier Cedex 05, France, 34295
        • CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH
      • Montpellier Cedex 05, France, 34295
        • CHU de Montpellier - Hôpital Lapeyronie
    • Gard
      • Nîmes Cedex 09, Gard, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically proven, localized, adenocarcinoma of the prostate who accept a curative treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All study patients
All patients included according to stated inclusion and exclusion criteria.
Biological: EPISPOT detection of the number of circulating cells
EPISPOT detection of the number of circulating, functional, prostate cells per unit blood
Biological: CellSearch detection of the number of circulating, functional, prostate cells
CellSearch detection of the number of circulating, functional, prostate cells per unit blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2012

Primary Completion (Actual)

December 8, 2014

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI/2010/SD-01
  • 2011-A00328-33 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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