Circulating And Intra-Tumoral Chemokines In Patients With... | NCT02869282

Studies
Circulating And Intra-Tumoral Chemokines In Patients With Prostate Cancer

NCT02869282

Sponsor

Institut Bergonié

Status

Withdrawn

Last Update Posted

Sep 17, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Blood samples
Urine samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal investigator left the study center and nobody took over the study.

Expanded Access Info

Start Date

Jun 2011Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jun 28, 2016

First Submission Date that Met QC Criteria

Aug 11, 2016

First Posted Date

Aug 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2025

Last Update Posted Date

Sep 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multicentric, observational, prospective, non-interventional study with occasional biological sample collection (serum bank, urine bank and tumor bank)

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective cohort		Levels of CXCL1, CCL5, CXCL8 and CXCL12 chemokines and of IL-6 cytokine by ELISA or Luminex technology.	Other: Blood samples Other: Urine samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood samples	Other	Additional blood samples at baseline, 6, 12, 18 and 24 months.	Prospective cohort

Outcomes Module

Primary Outcomes

Measure	Description	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		At baseline
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		At 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a localized or metastatic prostate adenocarcinoma

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Institut Bergonié		Bordeaux		33076	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided