- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02869282
Circulating And Intra-Tumoral Chemokines In Patients With Prostate Cancer (CHEMOPROST)
September 12, 2025 updated by: Institut Bergonié
Study Of The Expression Of Circulating And Intra-Tumoral Chemokines In Patients With Prostate Cancer
Multicentric, observational, prospective, non-interventional study with occasional biological sample collection (serum bank, urine bank and tumor bank)
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This project is an exploratory study, based on the hypothesis of involvement of chemokines in hormonal escape of prostate cancers.
The two main objectives are:
- To describe the variations in expression of chemokines in serum and urine level in patients with prostate cancer
- And to study the disease stage and intra-prostatic concentrations of chemokines based on serum and urine concentrations of chemokines before treatment initiation.
These estimates can be used in future trials set up for the management of prostate cancer
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bordeaux, France, 33076
- Institut Bergonie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with a localized or metastatic prostate adenocarcinoma
Description
Inclusion Criteria:
- Patients with a localized or metastatic prostate adenocarcinoma for which a new treatment will be implemented (hormone therapy for single biological relapse or relapses and metastatic hormone-sensitive) or chemotherapy (for biological relapses and / or metastatic hormone-resistant)
- Patients with a detectable PSA (Prostate-Specific Antigen)
- Patients who signed an informed consent
- Patients over 18 years
- Patients belonging to the social security scheme
Exclusion Criteria:
- Active Hepatitis B or C virus
- HIV positive
- Patients who have received prior chemotherapy
- Patients with a second neoplasia treated in the last 5 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prospective cohort
Levels of CXCL1, CCL5, CXCL8 and CXCL12 chemokines and of IL-6 cytokine by ELISA or Luminex technology.
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Additional blood samples at baseline, 6, 12, 18 and 24 months.
Additional urine samples at baseline, 6, 12, 18 and 24 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Concentration of chemokines initially detectable in the blood or urine and evolution during follow-up: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical
Time Frame: At baseline
|
At baseline
|
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Concentration of chemokines initially detectable in the blood or urine and evolution during follow-up: CXCL1, CXCL5, CXCL8, CXCL12, cytokine IL-6. Measurement was made by Luminex or elisa technical
Time Frame: At 6 months
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At 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2011
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
June 28, 2016
First Submitted That Met QC Criteria
August 11, 2016
First Posted (Estimated)
August 16, 2016
Study Record Updates
Last Update Posted (Estimated)
September 17, 2025
Last Update Submitted That Met QC Criteria
September 12, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Investigative Techniques
- Therapeutics
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
- Phlebotomy
Other Study ID Numbers
- IB2011-CHEMOPROST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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