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NCT Number: NCT03367208

Study of Metabolites Markers in Adjuvant Breast Cancer

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.

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Key information

Age range

10 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Antoine Lacassagne

Nice, Cedex 2, 06189, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Metabolomic profil diagnosis value

    Time frame: april 2017

Secondary outcomes

  1. correlation coefficient between glycolysis pathway metabolic concentration and 18FDG uptake

    Time frame: april 2017

  2. qualitative profile of tumor metabolic in serum

    Time frame: april 2017

  3. quantitative profile of tumor metabolic in serum

    Time frame: april 2017

  4. PFS comparisons at 2 years regarding the presence or absence of some metabolites (serum or tissue)

    Time frame: 2 years

  5. Test of concordance between metabolites found in tissues and serum sample

    Time frame: april 2017

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Acronym: EMMEEA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2017
Registry last updated
Sep 30, 2025

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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.

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