Trial record 4 of 5 for: "Familial prostate cancer"

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Epidemiologic and Genetic Study on Familial Prostate Cancer

This study is currently recruiting participants.

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

History of Changes

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:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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:

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.

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

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:

website from the sponsor which contains a description of the ProGene study and the associated publications This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Berthon P, Valeri A, Cohen-Akenine A, Drelon E, Paiss T, Wöhr G, Latil A, Millasseau P, Mellah I, Cohen N, Blanché H, Bellané-Chantelot C, Demenais F, Teillac P, Le Duc A, de Petriconi R, Hautmann R, Chumakov I, Bachner L, Maitland NJ, Lidereau R, Vogel W, Fournier G, Mangin P, Cussenot O, et al. Predisposing gene for early-onset prostate cancer, localized on chromosome 1q42.2-43. Am J Hum Genet. 1998 Jun;62(6):1416-24.

Correa-Cerro L, Wöhr G, Häussler J, Berthon P, Drelon E, Mangin P, Fournier G, Cussenot O, Kraus P, Just W, Paiss T, Cantú JM, Vogel W. (CAG)nCAA and GGN repeats in the human androgen receptor gene are not associated with prostate cancer in a French-German population. Eur J Hum Genet. 1999 Apr;7(3):357-62.

Correa-Cerro L, Berthon P, Häussler J, Bochum S, Drelon E, Mangin P, Fournier G, Paiss T, Cussenot O, Vogel W. Vitamin D receptor polymorphisms as markers in prostate cancer. Hum Genet. 1999 Sep;105(3):281-7.

Valeri A, Fournier G, Morin V, Morin JF, Drelon E, Mangin P, Teillac P, Berthon P, Cussenot O. Early onset and familial predisposition to prostate cancer significantly enhance the probability for breast cancer in first degree relatives. Int J Cancer. 2000 Jun 15;86(6):883-7.

Cancel-Tassin G, Latil A, Valéri A, Mangin P, Fournier G, Berthon P, Cussenot O. PCAP is the major known prostate cancer predisposing locus in families from south and west Europe. Eur J Hum Genet. 2001 Feb;9(2):135-42.

Latil AG, Azzouzi R, Cancel GS, Guillaume EC, Cochan-Priollet B, Berthon PL, Cussenot O. Prostate carcinoma risk and allelic variants of genes involved in androgen biosynthesis and metabolism pathways. Cancer. 2001 Sep 1;92(5):1130-7.

Cormier L, Guillemin F, Valéri A, Fournier G, Cussenot O, Mangin P, Litwin MS. Impact of prostate cancer screening on health-related quality of life in at-risk families. Urology. 2002 Jun;59(6):901-6.

Valeri A, Cormier L, Moineau MP, Cancel-Tassin G, Azzouzi R, Doucet L, Baschet F, Cussenot I, L'Her J, Berthon P, Mangin P, Cussenot O, Morin JF, Fournier G. Targeted screening for prostate cancer in high risk families: early onset is a significant risk factor for disease in first degree relatives. J Urol. 2002 Aug;168(2):483-7.

Azzouzi AR, Cochand-Priollet B, Mangin P, Fournier G, Berthon P, Latil A, Cussenot O. Impact of constitutional genetic variation in androgen/oestrogen-regulating genes on age-related changes in human prostate. Eur J Endocrinol. 2002 Oct;147(4):479-84.

Cancel-Tassin G, Latil A, Rousseau F, Mangin P, Bottius E, Escary JL, Berthon P, Cussenot O. Association study of polymorphisms in the human estrogen receptor alpha gene and prostate cancer risk. Eur Urol. 2003 Oct;44(4):487-90.

Fromont G, Joulin V, Chantrel-Groussard K, Vallancien G, Guillonneau B, Validire P, Latil A, Cussenot O. Allelic losses in localized prostate cancer: association with prognostic factors. J Urol. 2003 Oct;170(4 Pt 1):1394-7.

Latil A, Chêne L, Mangin P, Fournier G, Berthon P, Cussenot O. Extensive analysis of the 13q14 region in human prostate tumors: DNA analysis and quantitative expression of genes lying in the interval of deletion. Prostate. 2003 Sep 15;57(1):39-50.

Valeri A, Briollais L, Azzouzi R, Fournier G, Mangin P, Berthon P, Cussenot O, Demenais F. Segregation analysis of prostate cancer in France: evidence for autosomal dominant inheritance and residual brother-brother dependence. Ann Hum Genet. 2003 Mar;67(Pt 2):125-37.

Roumier X, Azzouzi R, Valéri A, Guillemin F, Fournier G, Cussenot O, Mangin P, Cormier L. Adherence to an annual PSA screening program over 3 years for brothers and sons of men with prostate cancer. Eur Urol. 2004 Mar;45(3):280-5; author reply 285-6.

Thuret R, Chantrel-Groussard K, Azzouzi AR, Villette JM, Guimard S, Teillac P, Berthon P, Houlgatte A, Latil A, Cussenot O. Clinical relevance of genetic instability in prostatic cells obtained by prostatic massage in early prostate cancer. Br J Cancer. 2005 Jan 31;92(2):236-40.

Fromont G, Chene L, Vidaud M, Vallancien G, Mangin P, Fournier G, Validire P, Latil A, Cussenot O. Differential expression of 37 selected genes in hormone-refractory prostate cancer using quantitative taqman real-time RT-PCR. Int J Cancer. 2005 Mar 20;114(2):174-81.

Rouprêt M, Fromont G, Bitker MO, Gattegno B, Vallancien G, Cussenot O. Outcome after radical prostatectomy in young men with or without a family history of prostate cancer. Urology. 2006 May;67(5):1028-32.

Azzouzi AR, Stoppa-Lyonnet D, Roupret M, Larre S, Mangin P, Cussenot O. BRCA2 mutation screening is clinically relevant in breast and early prostate cancer families. Int J Urol. 2007 May;14(5):445-6.

Cussenot O, Azzouzi AR, Nicolaiew N, Mangin P, Cormier L, Fournier G, Valeri A, Cancel-Tassin G. Low-activity V89L variant in SRD5A2 is associated with aggressive prostate cancer risk: an explanation for the adverse effects observed in chemoprevention trials using 5-alpha-reductase inhibitors. Eur Urol. 2007 Oct;52(4):1082-7. Epub 2007 Apr 13.

Yeager M, Orr N, Hayes RB, Jacobs KB, Kraft P, Wacholder S, Minichiello MJ, Fearnhead P, Yu K, Chatterjee N, Wang Z, Welch R, Staats BJ, Calle EE, Feigelson HS, Thun MJ, Rodriguez C, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Giovannucci E, Willett WC, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Gelmann EP, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover R, Hunter DJ, Chanock SJ, Thomas G. Genome-wide association study of prostate cancer identifies a second risk locus at 8q24. Nat Genet. 2007 May;39(5):645-9. Epub 2007 Apr 1.

Rouprêt M, Hupertan V, Yates DR, Catto JW, Rehman I, Meuth M, Ricci S, Lacave R, Cancel-Tassin G, de la Taille A, Rozet F, Cathelineau X, Vallancien G, Hamdy FC, Cussenot O. Molecular detection of localized prostate cancer using quantitative methylation-specific PCR on urinary cells obtained following prostate massage. Clin Cancer Res. 2007 Mar 15;13(6):1720-5.

Cussenot O, Azzouzi AR, Bantsimba-Malanda G, Gaffory C, Mangin P, Cormier L, Fournier G, Valeri A, Jouffe L, Roupret M, Fromont G, Sibony M, Comperat E, Cancel-Tassin G. Effect of genetic variability within 8q24 on aggressiveness patterns at diagnosis and familial status of prostate cancer. Clin Cancer Res. 2008 Sep 1;14(17):5635-9.

Ahn J, Berndt SI, Wacholder S, Kraft P, Kibel AS, Yeager M, Albanes D, Giovannucci E, Stampfer MJ, Virtamo J, Thun MJ, Feigelson HS, Cancel-Tassin G, Cussenot O, Thomas G, Hunter DJ, Fraumeni JF Jr, Hoover RN, Chanock SJ, Hayes RB. Variation in KLK genes, prostate-specific antigen and risk of prostate cancer. Nat Genet. 2008 Sep;40(9):1032-4; author reply 1035-6. No abstract available.

Fromont G, Yacoub M, Valeri A, Mangin P, Vallancien G, Cancel-Tassin G, Cussenot O. Differential expression of genes related to androgen and estrogen metabolism in hereditary versus sporadic prostate cancer. Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1505-9.

Thomas G, Jacobs KB, Yeager M, Kraft P, Wacholder S, Orr N, Yu K, Chatterjee N, Welch R, Hutchinson A, Crenshaw A, Cancel-Tassin G, Staats BJ, Wang Z, Gonzalez-Bosquet J, Fang J, Deng X, Berndt SI, Calle EE, Feigelson HS, Thun MJ, Rodriguez C, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Giovannucci E, Willett WC, Cussenot O, Valeri A, Andriole GL, Crawford ED, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover R, Hayes RB, Hunter DJ, Chanock SJ. Multiple loci identified in a genome-wide association study of prostate cancer. Nat Genet. 2008 Mar;40(3):310-5. Epub 2008 Feb 10.

Lou H, Yeager M, Li H, Bosquet JG, Hayes RB, Orr N, Yu K, Hutchinson A, Jacobs KB, Kraft P, Wacholder S, Chatterjee N, Feigelson HS, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Ma J, Gaziano JM, Stampfer M, Schumacher FR, Giovannucci E, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Anderson SK, Tucker M, Hoover RN, Fraumeni JF Jr, Thomas G, Hunter DJ, Dean M, Chanock SJ. Fine mapping and functional analysis of a common variant in MSMB on chromosome 10q11.2 associated with prostate cancer susceptibility. Proc Natl Acad Sci U S A. 2009 May 12;106(19):7933-8. Epub 2009 Apr 21.

Nicolaiew N, Cancel-Tassin G, Azzouzi AR, Grand BL, Mangin P, Cormier L, Fournier G, Giordanella JP, Pouchard M, Escary JL, Valeri A, Cussenot O. Association between estrogen and androgen receptor genes and prostate cancer risk. Eur J Endocrinol. 2009 Jan;160(1):101-6. Epub 2008 Oct 24.

Yeager M, Chatterjee N, Ciampa J, Jacobs KB, Gonzalez-Bosquet J, Hayes RB, Kraft P, Wacholder S, Orr N, Berndt S, Yu K, Hutchinson A, Wang Z, Amundadottir L, Feigelson HS, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Haiman CA, Henderson B, Kolonel L, Le Marchand L, Siddiq A, Riboli E, Key TJ, Kaaks R, Isaacs W, Isaacs S, Wiley KE, Gronberg H, Wiklund F, Stattin P, Xu J, Zheng SL, Sun J, Vatten LJ, Hveem K, Kumle M, Tucker M, Gerhard DS, Hoover RN, Fraumeni JF Jr, Hunter DJ, Thomas G, Chanock SJ. Identification of a new prostate cancer susceptibility locus on chromosome 8q24. Nat Genet. 2009 Oct;41(10):1055-7. Epub 2009 Sep 20.

Prokunina-Olsson L, Fu YP, Tang W, Jacobs KB, Hayes RB, Kraft P, Berndt SI, Wacholder S, Yu K, Hutchinson A, Spencer Feigelson H, Thun MJ, Diver WR, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Crawford ED, Haiman CA, Henderson BE, Kolonel L, Le Marchand L, Siddiq A, Riboli E, Travis R, Kaaks R, Isaacs WB, Isaacs SD, Grönberg H, Wiklund F, Xu J, Vatten LJ, Hveem K, Kumle M, Tucker M, Hoover RN, Fraumeni JF Jr, Hunter DJ, Thomas G, Chatterjee N, Chanock SJ, Yeager M. Refining the prostate cancer genetic association within the JAZF1 gene on chromosome 7p15.2. Cancer Epidemiol Biomarkers Prev. 2010 May;19(5):1349-55. Epub 2010 Apr 20.

Cussenot O, Azzouzi AR, Nicolaiew N, Fromont G, Mangin P, Cormier L, Fournier G, Valeri A, Larre S, Thibault F, Giordanella JP, Pouchard M, Zheng Y, Hamdy FC, Cox A, Cancel-Tassin G. Combination of polymorphisms from genes related to estrogen metabolism and risk of prostate cancers: the hidden face of estrogens. J Clin Oncol. 2007 Aug 20;25(24):3596-602.

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 May 23, 2013

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