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Clinical Trials/NCT01221168
NCT01221168
Recruiting
Not Applicable

ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial

Centre de Recherche sur les Pathologies Prostatiques5 sites in 1 country10,000 target enrollmentOctober 1996
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Centre de Recherche sur les Pathologies Prostatiques
Enrollment
10000
Locations
5
Primary Endpoint
Performance of genetic and molecular factors in predicting the risk of prostate cancer
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

The aims of the study are:

  • to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment,
  • to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.

Detailed Description

The impact of genetic factors on the natural history of prostate cancer (PC) is shown schematically at two levels: 1. first, at the constitutional level with germline alterations. Family history is found in 20% of PC patients. Different clinical entities associated with different modes of inheritance, susceptibility mutations or polymorphisms, define different evolutionary patterns. Also, studies suggested that some genetic polymorphisms alter the response to some treatments (such as recurrence after prostatectomy or radiotherapy) or adverse effects of those above (such as toxicity of radiation therapy). 2. secondly, PC is characterized by the accumulation of genetic alterations (somatic alterations or acquired mutations). These changes contribute in varying degrees to the aggressiveness of the disease (such as early metastatic potential) and treatment failure (such as resistance to radiation or hormone resistance). The purpose of this study is to establish a register, with a follow up of cohort type and a collection of biological samples: * For men with known prostate cancer. * For men with no prostate cancer after a screening procedure for this disease, so that their biological samples can be compared to those of men with prostate cancer. The registry data and collected biological samples are used to identify genetic and molecular factors involved in susceptibility, genesis and evolution of prostate cancers.

Registry
clinicaltrials.gov
Start Date
October 1996
End Date
December 2026
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre de Recherche sur les Pathologies Prostatiques
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patient with a histological confirmed prostate cancer
  • member of a hereditary prostate cancer family
  • healthy control men without prostate cancer

Exclusion Criteria

  • Absence of signed informed consent
  • refusal to participate in the study

Outcomes

Primary Outcomes

Performance of genetic and molecular factors in predicting the risk of prostate cancer

Time Frame: 20 years

Logistic regression and artificial neural networks will be used

Study Sites (5)

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