EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

Adenocarcinoma of the Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01402154
• Other study ID #: AOI/2010/SD-01
• Secondary ID: 2011-A00328-33
• Status: Active, not recruiting
• Start date: January 3, 2012
• Est. completion date: December 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 361
• Est. completion date: December 2021
• Est. primary completion date: December 8, 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate

Intervention

Biological:
• EPISPOT detection of the number of circulating cells
EPISPOT detection of the number of circulating, functional, prostate cells per unit blood
• CellSearch detection of the number of circulating, functional, prostate cells
CellSearch detection of the number of circulating, functional, prostate cells per unit blood

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque	Montpellier
France	Clinique Beau Soleil	Montpellier
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier Cedex 05
France	CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH	Montpellier Cedex 05
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between AUCs for the EPISPOT and Cellsearch Techniques	The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells	1 day