Epidemiologic and Genetic Study on Familial Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2010 by Centre de Recherche sur les Pathologies Prostatiques
Sponsor:
Information provided by:
Centre de Recherche sur les Pathologies Prostatiques
ClinicalTrials.gov Identifier:
NCT01221168
First received: October 13, 2010
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

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.

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial

Resource links provided by NLM:


Further study details as provided by Centre de Recherche sur les Pathologies Prostatiques:

Biospecimen Retention:   Samples With DNA

DNA extracted from blood/saliva or urine Serum


Estimated Enrollment: 6000
Study Start Date: October 1996
Estimated Study Completion Date: December 2016
Groups/Cohorts
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221168

Contacts
Contact: Olivier Cussenot, MD, PhD 00 33 1 56 01 64 95 olivier.cussenot@tnn.aphp.fr
Contact: Geraldine Cancel-Tassin, PhD 00 33 1 56 01 76 46 g.cancel@cerepp.org

Locations
France
Department of Urology, CHU Angers Recruiting
Angers, France, 49100
Principal Investigator: Abdel-Rahmene Azzouzi, MD, PhD         
Department of Urology, Hopital de la Cavale Blanche Recruiting
Brest, France, 29200
Principal Investigator: Georges Fournier, MD         
Sub-Investigator: Antoine Valéri, MD, PhD         
Department of Urology, CHU Dijon Recruiting
Dijon, France, 21000
Principal Investigator: Luc Cormier, MD, PhD         
Department of Urology, Hopital Tenon Recruiting
Paris, France, 75020
Principal Investigator: Olivier Cussenot, MD, PhD         
Department of Urology, Hopital Pitié-Salpetriere Recruiting
Paris, France, 75013
Principal Investigator: Marc-Olivier Bitker, MD         
Sub-Investigator: Morgan Roupret, MD, PhD         
Sponsors and Collaborators
Centre de Recherche sur les Pathologies Prostatiques
Investigators
Principal Investigator: Olivier Cussenot, MD, Ph.D. Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
Publications:

Responsible Party: Cussenot/Treasurer, Centre de Recherche sur les Pathologies Prostatiques (CeRePP)
ClinicalTrials.gov Identifier: NCT01221168     History of Changes
Other Study ID Numbers: ProGene
Study First Received: October 13, 2010
Last Updated: October 15, 2010
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority

Keywords provided by Centre de Recherche sur les Pathologies Prostatiques:
prostate
cancer
genetic
epidemiology
susceptibility

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014