Study of Metabolites Markers in Adjuvant Breast Cancer

Breast Neoplasms Clinical Trial

— EMMEEA  

Official title:

Study of Metabolites Markers in Adjuvant Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367208
• Other study ID #: 201707
• Status: Completed
• Phase: N/A
• First received: December 1, 2017
• Last updated: December 7, 2017
• Start date: April 12, 2017
• Est. completion date: May 23, 2017

Study information

• Verified date: December 2017
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The breast cancer is composed of multiple biological entities. Recent progress in molecular biology, DNA or RNA chip, permitted the global tumour genome or transcriptome study. Those technics, leads to an increased in the molecular biology knowledge and a better oncogenesis understanding. Breast cancer taxonomy was established following the tumor genetic profile. Moreover this classification is incomplete and didn't include the metabolic pathways other than hormonal or HER2 pathways.

The metabolomics is an expanding field of research exploring the metabolites in cells, tissues or biologics fluids. It allows assessing the variation activation of the different cellular metabolic pathways. In oncology, it could highlight the main metabolic disturbances, the interaction of tumor cells and to identify the metabolic pathways involved in oncogenesis using the tumor cells metabolites profiles.

Compared to genomic, the metabolomics integrated the impact of the cells environments on the cells biology. The cells environment plays, in fact, a key role in the oncogenesis and in the tumor cells phenotypes. The metabolomics, thus being a complementary approach of the genomic in order to assess a better knowledge of the impact of the extracellular environment on the tumor cell phenotype. In addition, the metabolomics analyses are fast and not expensive compatible with routine practice.

The main objective of this study is to highlight a metabolic alteration specific to certain tumors phenotypes in order to have better understanding of the biology of the numerous breast cancer entities and find some biomarkers which could be some possible therapeutic target. Using a high resolution mass spectrometer, the investigators will analyze 52 tumor samples from frozen breast surgical specimen preserved in the Centre Antoine lacassagne tumor bank. The tissue analysis could be associated with a serum sample analysis from the frozen serum bank of the Centre Antoine Lacassagne. With 30 patients who performed a 18 FDG-PET before the surgery, The investigators will analyzed the correlation between the tumoral activation of the glycolysis pathways, quantified with mass spectroscopy and the 18FDG uptake. Using the 17 frozen serums available, the investigators will perform a screening to identify some metabolites or metabolites profile which could be detected in the serum in order to develop a new liquid biopsy approach. This study is a retrospective study based on data and sample already available in the center and collected during the routine practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 23, 2017
• Est. primary completion date: May 23, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Patient with breast cancer who undergoes a initial surgery with frozen preservation of the surgical specimen in the Centre Antoine Lacassagne tumor bank

• Patient who sign the Biological research center consent allowing the the preservation of tumor and blood sample in biobank and use of the sample for research purpose

Exclusion Criteria:

• other treatment the initial surgery (neodjuvant chemotherapy...)

• Absence of tumor tissue available in the tumor bank

• Absence of Biological research center consent signed

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice	Cedex 2

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomic profil diagnosis value		april 2017
Secondary	correlation coefficient between glycolysis pathway metabolic concentration and 18FDG uptake		april 2017
Secondary	qualitative profile of tumor metabolic in serum		april 2017
Secondary	quantitative profile of tumor metabolic in serum		april 2017
Secondary	PFS comparisons at 2 years regarding the presence or absence of some metabolites (serum or tissue)		2 years
Secondary	Test of concordance between metabolites found in tissues and serum sample		april 2017