Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution

NCT ID: NCT03421015

Last Updated: 2019-11-07

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

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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case group

patients with biochemical recurrence and positive imaging (case group)

No interventions assigned to this group

Control Group

patients without biochemical recurrence (control group)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

New York Presbyterian Hospital

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnauld Villers, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Claude Huriez, CHRU

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Arnauld Villers, MD,PhD

Role: CONTACT

3 20 44 42 35 ext. +33

Other Identifiers

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2017-A01870-53

Identifier Type: OTHER

Identifier Source: secondary_id

2017_12

Identifier Type: -

Identifier Source: org_study_id

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