Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer (StoRM)

This study is currently recruiting participants.

Verified December 2012 by Centre Leon Berard

Sponsor:

Collaborator:

Centre de Recherche en Cancérologie de Lyon

Information provided by (Responsible Party):

Centre Leon Berard

ClinicalTrials.gov Identifier:

NCT01460186

First received: August 2, 2011

Last updated: December 4, 2012

Last verified: December 2012

History of Changes

Purpose

This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify germ line genetic factors that influence the risk of metastatic breast cancer.

1000 patients will be enrolled in this study. Blood samples will be collected after informed consent and inclusion in the study.

Patients will be treated and followed according to the standards of their treating center.

They will be followed during at least 5 years every 6 months for 3 years then every year.

Condition	Intervention
Breast Cancer Metastasis	Other: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)

Study Type:	Interventional
Official Title:	Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer : a Multicenter Non-randomized Prospective Cohort Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:

Germ line genetic factors associated with metastatic relapse [ Time Frame: at the end of enrollment (2 years) ] [ Designated as safety issue: No ]
Genetic determinants that predispose to a metastatic relapse of brest cancer by establishing germ line genetic variation based on single nucleotide polymorphisms of patients with metastatic breast cancer and comparing this variation to a cohort of patients with localized breast cancer (SIGNAL study)(correlation between polymorphisms and risk of relapse)

Secondary Outcome Measures:

Genetic determinants that predispose to specific metastatic localizations [ Time Frame: at the end of enrollment (2 years) ] [ Designated as safety issue: No ]
Germ line polymorphisms will be analysed and tested for association with specific metastatic localizations as bone, lung, liver or central nervous system.
Genetic determinants that predispose to metastatic relapse of specific molecular subtype of breast cancer [ Time Frame: at the end of enrollment (2 years) ] [ Designated as safety issue: No ]
Germ line polymorphisms will be analysed and tested for association with metastatic relapse as a function of immunohistochemical/molecular characteristics of the primary tumor
Overall survival [ Time Frame: At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up) ] [ Designated as safety issue: No ]
Evaluate as a function of germ line polymorphisms overall survival after first-line treatment in metastatic setting
Progression free survival [ Time Frame: At the end of the study (7 years: 2 years of enrollment and 5 years of follow-up) ] [ Designated as safety issue: No ]
Evaluate as a function of germ line polymorphisms progression free survival after first-line treatment in metastatic setting

Estimated Enrollment:	1000
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2023
Estimated Primary Completion Date:	December 2023 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Blood samples	Other: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer) Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study.

Detailed Description:

The StoRM trial is designed for analysis in association with the SIGNAL study which aims to decipher the genetic risk of breast cancer displaying amplification of the HER2 gene as well as resistance or toxicity to adjuvant treatments. SIGNAL study is in the process of recruiting 6000 localized breast cancer patients.

The purpose of the StoRM trial is to create a cohort of 1000 patients with metastatic breast cancer including detailed epidemiologic and treatment data. Using germ line polymorphisms in these patients and comparing them to patients with localized cancer from the SIGNAL study, the investigators will answer questions specific to the genetic influence on the prognosis of breast cancer and its response to treatments in the metastatic phase.

Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study. To simplify the evolution of the study and to avoid all confusion, the sample collection procedures followed will be identical to those used in the SIGNAL study.

As the samples are received at the biological resource center, the plasma will be aliquoted into a 500 µl tube and frozen at -80° C. DNA will be extracted using standard protocols. Plasma and DNA will be stored in anticipation of genetic analyses. An aliquot of the DNA sample will be genotyped for a panel of high-density genetic markers covering the whole genome, for genome-wide association studies.

The collected plasma may also be used for analyses to determine the expression profile of proteins, alone or combined with genetic factors that allow distinguishing between groups of patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with a histologically proven breast cancer, with metastatic progression diagnosed within one year (inclusion of patients who have a metastatic progression more than one year ago would favor the inclusion of patients with indolent cancer, possibly biasing the study) or locally advanced (no curative treatment)
ER, PR and HER2 status known
Age >= 18 years
Affiliation with a social security scheme
Signed informed consent

Exclusion Criteria:

Coexisting or other cancer diagnosed within the previous 5 years that may be responsible for the current metastasis
Patient who cannot follow medical surveillance due to geographical, social or psychological reasons
Patient included in the SIGNAL study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460186

Contacts

Contact: Ellen BLANC	+ 33 4 78 78 29 67	ellen.blanc@lyon.unicancer.fr
Contact: Justine SEMAL	+33 4 78 78 29 22	justine.semal@lyon.unicancer.fr

Locations

France
Hôpital Jean Minjoz - CHU Besançon	Not yet recruiting
BESANCON Cedex, France, 25030
Principal Investigator: Xavier PIVOT, MD
Institut Bergonié	Not yet recruiting
Bordeaux, France, 33000
Principal Investigator: Hervé BONNEFOI, MD
Centre François Baclesse	Not yet recruiting
Caen, France, 14000
Principal Investigator: Thierry DELOZIER, MD
Centre Georges François Leclerc	Not yet recruiting
DIJON Cedex, France, 21079
Principal Investigator: Bruno COUDERT, MD
Institut Daniel Hollard	Not yet recruiting
Grenoble, France, 38028
Principal Investigator: Claire GARNIER TIXIDRE, MD
Hôpital Dupuytren	Not yet recruiting
LIMOGES Cedex, France, 87042
Principal Investigator: Nicole TUBIANA-MATHIEU, MD
Centre Léon Bérard	Recruiting
LYON Cedex 08, France, 69373
Contact: Ellen BLANC +33 4 78 78 29 67 ellen.blanc@lyon.unicancer.fr
Principal Investigator: Thomas BACHELOT, MD
Institut Paoli Calmettes	Not yet recruiting
Marseille, France, 13009
Principal Investigator: Anthony GONCALVES, MD
Val d'Aurelle	Not yet recruiting
Montpellier, France, 34000
Principal Investigator: William JACOT, MD
Centre Antoine Lacassagne	Not yet recruiting
Nice, France, 06000
Principal Investigator: Jean-Marc FERRERO, MD
Institut Curie	Not yet recruiting
PARIS Cedex 05, France, 75248
Principal Investigator: Jean-Yves PIERGA, MD
Institut Jean Godinot	Not yet recruiting
Reims, France, 51100
Principal Investigator: Christelle JOUANNAUD, MD
Centre René Gauducheau	Not yet recruiting
SAINT HERBLAIN Cedex, France, 44805
Principal Investigator: Mario CAMPONE, MD
Centre Paul Strauss	Recruiting
Strasbourg, France, 67065
Principal Investigator: Thierry PETIT, MD
Institut Claudius Regaud	Not yet recruiting
TOULOUSE Cedex, France, 31052
Principal Investigator: Florence DALENC, MD
Centre Alexis Vautrin	Recruiting
Vandoeuvre les Nancy, France, 54511
Principal Investigator: Maria RIOS, MD
Institut Gustave Roussy	Not yet recruiting
Villejuif, France, 94805
Principal Investigator: Suzette DELALOGE, MD

Sponsors and Collaborators

Centre Leon Berard

Centre de Recherche en Cancérologie de Lyon

Investigators

Principal Investigator:

Thomas BACHELOT, MD

Centre Léon Bérard

More Information

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Lander ES, Linton LM, Birren B, Nusbaum C, Zody MC, Baldwin J, Devon K, Dewar K, Doyle M, FitzHugh W, Funke R, Gage D, Harris K, Heaford A, Howland J, Kann L, Lehoczky J, LeVine R, McEwan P, McKernan K, Meldrim J, Mesirov JP, Miranda C, Morris W, Naylor J, Raymond C, Rosetti M, Santos R, Sheridan A, Sougnez C, Stange-Thomann N, Stojanovic N, Subramanian A, Wyman D, Rogers J, Sulston J, Ainscough R, Beck S, Bentley D, Burton J, Clee C, Carter N, Coulson A, Deadman R, Deloukas P, Dunham A, Dunham I, Durbin R, French L, Grafham D, Gregory S, Hubbard T, Humphray S, Hunt A, Jones M, Lloyd C, McMurray A, Matthews L, Mercer S, Milne S, Mullikin JC, Mungall A, Plumb R, Ross M, Shownkeen R, Sims S, Waterston RH, Wilson RK, Hillier LW, McPherson JD, Marra MA, Mardis ER, Fulton LA, Chinwalla AT, Pepin KH, Gish WR, Chissoe SL, Wendl MC, Delehaunty KD, Miner TL, Delehaunty A, Kramer JB, Cook LL, Fulton RS, Johnson DL, Minx PJ, Clifton SW, Hawkins T, Branscomb E, Predki P, Richardson P, Wenning S, Slezak T, Doggett N, Cheng JF, Olsen A, Lucas S, Elkin C, Uberbacher E, Frazier M, Gibbs RA, Muzny DM, Scherer SE, Bouck JB, Sodergren EJ, Worley KC, Rives CM, Gorrell JH, Metzker ML, Naylor SL, Kucherlapati RS, Nelson DL, Weinstock GM, Sakaki Y, Fujiyama A, Hattori M, Yada T, Toyoda A, Itoh T, Kawagoe C, Watanabe H, Totoki Y, Taylor T, Weissenbach J, Heilig R, Saurin W, Artiguenave F, Brottier P, Bruls T, Pelletier E, Robert C, Wincker P, Smith DR, Doucette-Stamm L, Rubenfield M, Weinstock K, Lee HM, Dubois J, Rosenthal A, Platzer M, Nyakatura G, Taudien S, Rump A, Yang H, Yu J, Wang J, Huang G, Gu J, Hood L, Rowen L, Madan A, Qin S, Davis RW, Federspiel NA, Abola AP, Proctor MJ, Myers RM, Schmutz J, Dickson M, Grimwood J, Cox DR, Olson MV, Kaul R, Raymond C, Shimizu N, Kawasaki K, Minoshima S, Evans GA, Athanasiou M, Schultz R, Roe BA, Chen F, Pan H, Ramser J, Lehrach H, Reinhardt R, McCombie WR, de la Bastide M, Dedhia N, Blöcker H, Hornischer K, Nordsiek G, Agarwala R, Aravind L, Bailey JA, Bateman A, Batzoglou S, Birney E, Bork P, Brown DG, Burge CB, Cerutti L, Chen HC, Church D, Clamp M, Copley RR, Doerks T, Eddy SR, Eichler EE, Furey TS, Galagan J, Gilbert JG, Harmon C, Hayashizaki Y, Haussler D, Hermjakob H, Hokamp K, Jang W, Johnson LS, Jones TA, Kasif S, Kaspryzk A, Kennedy S, Kent WJ, Kitts P, Koonin EV, Korf I, Kulp D, Lancet D, Lowe TM, McLysaght A, Mikkelsen T, Moran JV, Mulder N, Pollara VJ, Ponting CP, Schuler G, Schultz J, Slater G, Smit AF, Stupka E, Szustakowski J, Thierry-Mieg D, Thierry-Mieg J, Wagner L, Wallis J, Wheeler R, Williams A, Wolf YI, Wolfe KH, Yang SP, Yeh RF, Collins F, Guyer MS, Peterson J, Felsenfeld A, Wetterstrand KA, Patrinos A, Morgan MJ, de Jong P, Catanese JJ, Osoegawa K, Shizuya H, Choi S, Chen YJ; International Human Genome Sequencing Consortium. Initial sequencing and analysis of the human genome. Nature. 2001 Feb 15;409(6822):860-921. Erratum in: Nature 2001 Aug 2;412(6846):565. Nature 2001 Jun 7;411(6838):720. Szustakowki, J [corrected to Szustakowski, J].

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Responsible Party:	Centre Leon Berard
ClinicalTrials.gov Identifier:	NCT01460186 History of Changes
Other Study ID Numbers:	StoRM
Study First Received:	August 2, 2011
Last Updated:	December 4, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:

Germ line polymorphisms

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms

Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

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