Bringing of PET-TDM FDG in the Determination of the Characteristics of

Status Active, not recruiting

Clinical Trial Summary

"Triple Negative" breast cancers are a heterogeneous group characterized by the absence of hormone receptors to estrogen, progesterone and the absence of expression or amplification of the HER-2 gene. This type of cancer is associated with an adverse clinical profile with a high risk of early metastatic relapse. Accurate identification of prognostic factors, as well as predictors of therapeutic response, and the contribution of targeted therapies are avenues for improving the management and survival of patients with these cancers. Such an approach requires optimal biological characterization, allowing us to understand the complexity of this group of tumors, and requires multidisciplinary collaboration in clinical trials involving anatomopathology, oncology and morpho-functional imaging. The investigator's goal is to characterize by innovative methods (anatomo-pathological in particular Of Immunohistochemistry, and morpho-functional imaging (TEP-TDM FDG) semi-quantitative and texture) in a population of Triple Negative Breast Cancer scans better knowledge of this entity that can lead to the development of relevant therapeutic strategies and especially more adapted in the context of precision and personalized medicine.

Clinical Trial Description

120 consecutive patients with "Triple Negative" breast cancers operatable from the outset will be included in the study - To assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years. - To assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immuno-histochemistry parameters for 2-year event-free survival . - To assess correlations between continuous PET-TDM FDG texture parameters and Immuno-histochemistry. - To assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immuno-histochemistry defined as relevant to 2-year event-free survival . - Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04226222
Study type	Observational
Source	Institut Cancerologie de l'Ouest
Contact
Status	Active, not recruiting
Phase
Start date	November 5, 2019
Completion date	October 22, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bringing of PET-TDM FDG in the Determination of the Characteristics of Primary Mammary Tumors TrIple Negatives — FICTION

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms