EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01402154
First received: July 25, 2011
Last updated: March 26, 2015
Last verified: March 2015
  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.


Enrollment: 361
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque
Montpellier, France, 34298
Clinique Beau Soleil
Montpellier, France, 34070
CHU de Montpellier - Hôpital Lapeyronie
Montpellier Cedex 05, France, 34295
CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH
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: March 26, 2015
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
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on August 30, 2015