EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01402154
First received: July 25, 2011
Last updated: June 23, 2014
Last verified: June 2014

July 25, 2011
June 23, 2014
January 2012
January 2018   (final data collection date for primary outcome measure)
The difference between AUCs for the EPISPOT and Cellsearch Techniques [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells
Same as current
Complete list of historical versions of study NCT01402154 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Following the completion of the biological analyses required for this study, leftover tubes may be placed in the Nîmes University Hospital biological collection for future ancillary studies, if patients are agreed with this. The samples concerned include EDTA and CellSave tubes for each patient.

Non-Probability Sample

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

Adenocarcinoma of the Prostate
  • 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
All study patients
All patients included according to stated inclusion and exclusion criteria.
Interventions:
  • Biological: EPISPOT detection of the number of circulating cells
  • Biological: CellSearch detection of the number of circulating, functional, prostate cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
January 2018
January 2018   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Stéphane Droupy, MD PhD +33.(0)4.66.68.33.51 stephane.droupy@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr
France
 
NCT01402154
AOI/2010/SD-01, 2011-A00328-33
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Stéphane Droupy, MD PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP