Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution (CHRU-WCMC)

November 6, 2019 updated by: University Hospital, Lille

Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence

Developing a genetic study on localized or locally advanced prostate cancer. The aim of the study is to identify genomic alteration predictive of metastatic recurrence in the context of primary heterogeneity, by using the next generation sequencing (NGS) techniques.

Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Claude Huriez, CHRU
        • Principal Investigator:
          • Arnaud Villers, MD,PhD
        • Sub-Investigator:
          • Thomas Caes, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients managed by radical prostatectomy for prostate cancer

Description

Inclusion Criteria:

  • Patients managed by radical prostatectomy for prostate cancer between 2000 and 2016.
  • Follow up > 6 years
  • Negative pre surgical extension assessment
  • Prognostic Grade Groups (OGG) III-IV-V
  • Biochemical recurrence defined by 2 consecutive PSA rises ≥ 0,2 ng/mL
  • Metastasis positive imaging

Exclusion Criteria:

  • Neoadjuvant therapy
  • Follow up < 6 years
  • Prognostic Grade Groups (PGG) I-II
  • Biochemical recurrence with metastasis negative imaging

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

Cohorts and Interventions

Group / Cohort
case group
patients with biochemical recurrence and positive imaging (case group)
Control Group
patients without biochemical recurrence (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The genetic alteration frequencies of TMPRSS2-ERG gene fusion
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),
Time Frame: Baseline
Baseline
Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),
Time Frame: Baseline
Baseline
Frequency of point mutations modifying protein function (SPOP)
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Weill Medical College of Cornell University
New York Presbyterian Hospital

Investigators

  • Principal Investigator: Arnauld Villers, MD,PhD, University Hospital, Lille

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)

May 1, 2017

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_12
  • 2017-A01870-53 (Other Identifier: ID-RCB number, ANSM)

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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