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AzTrials

Breast NeoplasmsEMMEEANCT03367208

Study of Metabolites Markers in Adjuvant Breast Cancer

An observational study of Breast Neoplasms, run by Centre Antoine Lacassagne at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 10 years and older, women only
Conditions the study is for
Breast Neoplasms
How many people
52 participants
Where
1 siteFrance
Study dates
12 Apr 2017to 23 May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patient who undergoes a initial surgery for a breast cancer in the Centre Antoine Lacassagne with surgical specimen available for the research

Who may be able to join

  • 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

Who cannot join

  • other treatment the initial surgery (neodjuvant chemotherapy...)
  • Absence of tumor tissue available in the tumor bank
  • Absence of Biological research center consent signed

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Antoine Lacassagne

    Nice, Cedex 2, 06189

Other trials in France

About this study

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.

Read more

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.

Keywords
metabolomic
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolomic profil diagnosis value

    Measured: april 2017

Secondary outcomes (5)
  1. correlation coefficient between glycolysis pathway metabolic concentration and 18FDG uptake

    Measured: april 2017

  2. qualitative profile of tumor metabolic in serum

    Measured: april 2017

  3. quantitative profile of tumor metabolic in serum

    Measured: april 2017

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

    Measured: 2 years

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

    Measured: april 2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2017
  2. Study start12 Apr 2017
  3. Primary completion23 May 2017
  4. Study completion23 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03367208
Sponsor's protocol ID
2017/07
Acronym
EMMEEA
Status last verified
Dec 2017
First submitted
1 Dec 2017
Last updated
30 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Centre Antoine Lacassagne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolomic profil diagnosis value (time frame: april 2017). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.

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