Epidemiologic and Genetic Study on Familial Prostate Cancer
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||ProGene: Etude Genetique et Epidemiologique du Cancer de la Prostate Familial|
- Performance of genetic and molecular factors in predicting the risk of prostate cancer [ Time Frame: 20 years ] [ Designated as safety issue: No ]Logistic regression and artificial neural networks will be used
Biospecimen Retention: Samples With DNA
DNA extracted from blood/saliva or urine Serum
|Study Start Date:||October 1996|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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.
The impact of genetic factors on the natural history of prostate cancer (PC) is shown schematically at two levels:
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221168
|Contact: Olivier Cussenot, MD, PhD||00 33 1 56 01 64 firstname.lastname@example.org|
|Contact: Geraldine Cancel-Tassin, PhD||00 33 1 42 16 00 email@example.com|
|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 Pitié-Salpetriere||Recruiting|
|Paris, France, 75013|
|Principal Investigator: Marc-Olivier Bitker, MD|
|Sub-Investigator: Morgan Roupret, MD, PhD|
|Department of Urology, Hopital Tenon||Recruiting|
|Paris, France, 75020|
|Principal Investigator: Olivier Cussenot, MD, PhD|
|Principal Investigator:||Olivier Cussenot, MD, Ph.D.||Assistance Publique - Hôpitaux de Paris|