EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01402154

Collaborator

(none)

361

Enrollment

Locations

118.9

Anticipated Duration (Months)

72.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

361 participants

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

Actual Study Start Date :

Jan 3, 2012

Actual Primary Completion Date :

Dec 8, 2014

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

The difference between AUCs for the EPISPOT and Cellsearch Techniques [1 day]
The difference between the AUCs (area under the curve) for the EPISPOT and Cellsearch techniques for detecting functional, circulating prostate cells

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard	France	30029
2	CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH	Montpellier Cedex 05		France	34295
3	CHU de Montpellier - Hôpital Lapeyronie	Montpellier Cedex 05		France	34295
4	Clinique Beau Soleil	Montpellier		France	34070
5	Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque	Montpellier		France	34298

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Stéphane Droupy, MD PhD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01402154

Other Study ID Numbers:

AOI/2010/SD-01
2011-A00328-33

First Posted:

Jul 26, 2011

Last Update Posted:

Aug 5, 2021

Last Verified:

Aug 1, 2021

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Aug 5, 2021