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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460186
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Centre de Recherche en Cancérologie de Lyon
Information provided by (Responsible Party):
Centre Leon Berard

Tracking Information
First Submitted Date  ICMJE August 2, 2011
First Posted Date  ICMJE October 26, 2011
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE December 2011
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
Germ line genetic factors associated with metastatic relapse [ Time Frame: at the end of enrollment (2 years) ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
  • Genetic determinants that predispose to specific metastatic localizations [ Time Frame: at the end of enrollment (2 years) ]
    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) ]
    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) ]
    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) ]
    Evaluate as a function of germ line polymorphisms progression free survival after first-line treatment in metastatic setting
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
  • Genetic determinants that predispose to specific metastatic localizations [ Time Frame: at the end of enrollment (2 years) ]
    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) ]
    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) ]
    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) ]
    Evaluate as a function of germ line polymorphisms progression free survival after first-line treatment in metastatic setting
  • Treatment complications as a function of germ line polymorphisms [ Time Frame: After first line metastatic treatment, an expected average of 3 years ]
    Germ line polymorphisms will be analysed and tested for association with main toxicities, defined as grade 4 NCI-CTCAE version 4.0 non-hematological toxicities during first-line treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer
Official Title  ICMJE Evaluation of the Predictive and Prognostic Value of Germ-line Polymorphisms in Patients With Metastatic Breast Cancer : a Multicenter Non-randomized Prospective Cohort Study
Brief Summary

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.

1500 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.

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 1500 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Other
Condition  ICMJE
  • Breast Cancer
  • Metastasis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Blood samples
Intervention: Other: Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 24, 2011)
1000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women with a histologically proven breast adenocarcinoma, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460186
Other Study ID Numbers  ICMJE StoRM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Leon Berard
Study Sponsor  ICMJE Centre Leon Berard
Collaborators  ICMJE Centre de Recherche en Cancérologie de Lyon
Investigators  ICMJE
Principal Investigator: Thomas BACHELOT, MD Centre Leon Berard
PRS Account Centre Leon Berard
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP