Epidemiologic and Genetic Study on Familial Prostate Cancer

February 11, 2015 updated by: Centre de Recherche sur les Pathologies Prostatiques

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

6000

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 Contact Backup

  • Name: Geraldine Cancel-Tassin, PhD
  • Phone Number: 00 33 1 42 16 00 25
  • Email: g.cancel@cerepp.org

Study Locations

  • France
      • Angers, France, 49100
        • Recruiting
        • Department of Urology, CHU Angers
        • Principal Investigator:
          • Abdel-Rahmene Azzouzi, MD, PhD
      • Brest, France, 29200
        • Recruiting
        • Department of Urology, Hopital de la Cavale Blanche
        • Principal Investigator:
          • Georges Fournier, MD
        • Sub-Investigator:
          • Antoine Valéri, MD, PhD
      • Dijon, France, 21000
        • Recruiting
        • Department of Urology, CHU Dijon
        • Principal Investigator:
          • Luc Cormier, MD, PhD
      • Paris, France, 75013
        • Recruiting
        • Department of Urology, Hopital Pitié-Salpetriere
        • Principal Investigator:
          • Marc-Olivier Bitker, MD
        • Sub-Investigator:
          • Morgan Roupret, MD, PhD
      • Paris, France, 75020
        • Recruiting
        • Department of Urology, Hopital Tenon
        • Principal Investigator:
          • Olivier Cussenot, MD, PhD

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men with or without prostate cancer are recruited in different departments of urology or care centers in France.

For hereditary prostate cancer, patients and their family members are referred by all urologists from France.

Description

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

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
Men with or without Prostate Cancer

Men with a histological confirmed prostate cancer, and their family members in case of hereditary prostate cancer.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 years

Collaborators and Investigators

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

Sponsor

Centre de Recherche sur les Pathologies Prostatiques

Investigators

  • Principal Investigator: Olivier Cussenot, MD, Ph.D., Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 1996

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (ESTIMATE)

October 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProGene

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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