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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421015
Recruitment Status : Unknown
Verified November 2019 by University Hospital, Lille.
Recruitment status was:  Recruiting
First Posted : February 5, 2018
Last Update Posted : November 7, 2019
Sponsor:
Collaborators:
Weill Medical College of Cornell University
New York Presbyterian Hospital
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:

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.


Condition or disease
Prostatic Neoplasms

Study Design
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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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


Outcome Measures
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Primary Outcome Measures :
  1. The genetic alteration frequencies of TMPRSS2-ERG gene fusion [ Time Frame: Baseline ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients managed by radical prostatectomy for prostate cancer
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421015


Contacts
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Contact: Arnauld Villers, MD,PhD 3 20 44 42 35 ext +33 arnauld.villers@chru-lille.fr

Locations
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France
Hôpital Claude Huriez, CHRU Recruiting
Lille, France
Principal Investigator: Arnaud Villers, MD,PhD         
Sub-Investigator: Thomas Caes, MD         
Sponsors and Collaborators
University Hospital, Lille
Weill Medical College of Cornell University
New York Presbyterian Hospital
Investigators
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Principal Investigator: Arnauld Villers, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03421015    
Other Study ID Numbers: 2017_12
2017-A01870-53 ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
localized prostate cancer
prostatectomy
biomarkers
metastatic recurrence
genomic
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases