EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

NCT ID: NCT01402154

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

361 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-03

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adenocarcinoma of the Prostate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All study patients

All patients included according to stated inclusion and exclusion criteria.

EPISPOT detection of the number of circulating cells

Intervention Type BIOLOGICAL

EPISPOT detection of the number of circulating, functional, prostate cells per unit blood

CellSearch detection of the number of circulating, functional, prostate cells

Intervention Type BIOLOGICAL

CellSearch detection of the number of circulating, functional, prostate cells per unit blood

Interventions

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EPISPOT detection of the number of circulating cells

EPISPOT detection of the number of circulating, functional, prostate cells per unit blood

Intervention Type BIOLOGICAL

CellSearch detection of the number of circulating, functional, prostate cells

CellSearch detection of the number of circulating, functional, prostate cells per unit blood

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Droupy, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Site Status

Clinique Beau Soleil

Montpellier, , France

Site Status

CHU de Montpellier - Hôpital Lapeyronie - Plateforme LCCRH

Montpellier, , France

Site Status

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status

Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2011-A00328-33

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2010/SD-01

Identifier Type: -

Identifier Source: org_study_id

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