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
  Purpose

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.


Condition Intervention
Adenocarcinoma of the Prostate
Biological: EPISPOT detection of the number of circulating cells
Biological: CellSearch detection of the number of circulating, functional, prostate cells

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pre-treatment Detection of Circulating, Functional, Prostate Cells Among Adenocarcinoma Patients: an Evaluation of the EPISPOT Technique

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 360
Study Start Date: January 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402154

Contacts
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

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Stéphane Droupy, MD PhD         
Sub-Investigator: Pierre Costa, MD PhD         
Sub-Investigator: Françoise Bons, MD         
Sub-Investigator: Thibaut Murez, MD         
Clinique Beau Soleil Recruiting
Montpellier, France, 34070
Sub-Investigator: Xavier Rebillard, MD         
Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque Recruiting
Montpellier, France, 34298
Sub-Investigator: David Azria, MD PhD         
Sub-Investigator: Olivier Riou, MD         
CHU de Montpellier - Hôpital Lapeyronie Recruiting
Montpellier Cedex 05, France, 34295
Sub-Investigator: Jacques Guiter, MD PhD         
Sub-Investigator: Rodolphe Thuret, MD         
CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH Active, not recruiting
Montpellier Cedex 05, France, 34295
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Stéphane Droupy, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01402154     History of Changes
Other Study ID Numbers: AOI/2010/SD-01, 2011-A00328-33
Study First Received: July 25, 2011
Last Updated: June 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014