Skip to main content
OpenTrials
Completed

NCT Number: NCT01460186

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Jean Minjoz - CHU Besançon, Besançon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)

Other

Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Cancer Research Center of Lyon

Registry information

Official study 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

Acronym: StoRM

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2011
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.