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

NCT ID: NCT01460186

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2017-09-01

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.

Conditions

Breast Cancer; Metastasis

Study Design

• Primary Study Purpose: OTHER

Study Groups

Blood samples

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche en Cancérologie de Lyon

UNKNOWN

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas BACHELOT, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Hôpital Jean Minjoz - CHU Besançon

Besançon, , France

Institut Bergonié

Bordeaux, , France

Centre François Baclesse

Caen, , France

Centre Georges François Leclerc

Dijon, , France

Institut Daniel Hollard

Grenoble, , France

Hôpital Dupuytren

Limoges, , France

Centre Léon Bérard

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

Val d'Aurelle

Montpellier, , France

Centre Antoine Lacassagne

Nice, , France

Institut Curie

Paris, , France

Institut Jean Godinot

Reims, , France

Centre René Gauducheau

Saint-Herblain, , France

Centre Paul Strauss

Strasbourg, , France

Institut Claudius Regaud

Toulouse, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

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Other Identifiers

StoRM

Identifier Type: -

Identifier Source: org_study_id