EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients
This study is currently recruiting participants.
Verified May 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01402154
First received: July 25, 2011
Last updated: May 14, 2013
Last verified: May 2013
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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
| Estimated Enrollment: | 360 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 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
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 | |
| 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: | May 14, 2013 |
| 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 Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013