Bringing of PET-TDM FDG in the Determination of the Characteristics of Primary Mammary Tumors TrIple Negatives (FICTION)
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|ClinicalTrials.gov Identifier: NCT04226222|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
"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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Diagnostic Test: TEP-TDM FDG|
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 Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Bringing Semi-quantitative PET-TDM FDG Data and Texture Analysis to Clinical, Histological and Immuno-histochemical Characteristics of Primary Mammary Tumors Triple Negatives|
|Actual Study Start Date :||November 5, 2019|
|Estimated Primary Completion Date :||October 30, 2023|
|Estimated Study Completion Date :||October 30, 2023|
Triple negative Breast Cancer
Triple Negative Breast Cancer operatable from the outset
Diagnostic Test: TEP-TDM FDG
Semi-quantitative PET-TDM FDG Data and Texture Analysis
- Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years. [ Time Frame: 2 years ]
The 2-year event-free survival rate based on the texture parameters of the PET-TDM FDG.
Event free survival is the duration between the date of diagnosis and the date of the first event (relapse, death) or the date of the last news without event.
- assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immunohistochemistry parameters for 2-year event-free survival . [ Time Frame: 2 years ]2-year event-free survival rate based on univariate analysis of standard, semi-quantitative parameters of PET-TDM FDG and innovative Immunohistochemistry parameters.
- To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry. [ Time Frame: 2 years ]Correlation coefficients between the continuous criteria of the FDG PET texture parameters and those of the Immunohistochemistry.
- assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry defined as relevant to 2-year event-free survival [ Time Frame: 2 years ]2-year event-free survival rate in multivariate analysis according to standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry.
- Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups [ Time Frame: 2 years ]2-year event-free survival rate depending on the risk groups determined from the nomogram score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226222
|Contact: Caroline ROUSSEAUemail@example.com|
|Contact: Nadia FLEURY||+33 firstname.lastname@example.org|
|Principal Investigator:||Caroline ROUSSEAUemail@example.com|