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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
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: TEP-TDM FDG

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with triple negative breast cancer operatable from the outset will be
Criteria

Inclusion Criteria:

  • Patient with biopsy-proven triple-negative breast cancer, newly diagnosed, naïve from any treatment.
  • Age - 18.
  • Performance Status (PS) : 0 or 1.
  • No metastasis on the extension balance.
  • Treatment provided immediately by lumpectomy or mastectomy, and accepted by the patient.

Exclusion Criteria:

  • Severe illness or comorbidity at risk.
  • A history of cancer within 5 years, with the exception of skin carcinomas (other than melanoma) or in-situ cervical carcinomas.
  • Patient candidate for neo-adjuvant therapy.

Information from the National Library of Medicine

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


Contacts
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Contact: Caroline ROUSSEAU +33240679900 caroline.rousseau@ico.unicancer.fr
Contact: Nadia FLEURY +33 240679747 nadia.fleury@ico.unicancer.fr

Locations
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France
Institut de Cancerologie de L'Ouest Recruiting
Saint-Herblain, France, 44805
Contact: Caroline ROUSSEAU       caroline.rousseau@ico.unicancer.fr   
Contact: Nadia FLEURY    +33 240679747    nadia.fleury@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Principal Investigator: Caroline ROUSSEAU caroline.rousseau@ico.unicancer.fr
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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT04226222    
Other Study ID Numbers: ICO-2019-03
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases