Breast CancerFICTIONNCT04226222
Bringing of PET-TDM FDG in the Determination of the Characteristics of Primary Mammary Tumors TrIple Negatives
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TEP-TDM FDG
- How many people
- 132 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Nov 2019to 22 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with triple negative breast cancer operatable from the outset will be
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut de Cancérologie de l'Ouest
Angers, 49055
Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805
About this study
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
"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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- TEP-TDM FDG
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEP-TDM FDGDiagnostic test
Semi-quantitative PET-TDM FDG Data and Texture Analysis
| Study group | Role | What they receive |
|---|---|---|
| Triple negative Breast Cancer | Triple Negative Breast Cancer operatable from the outset Receives: Diagnostic Test: TEP-TDM FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 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.
Measured: 2 years
Secondary outcomes (4)
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 .
2-year event-free survival rate based on univariate analysis of standard, semi-quantitative parameters of PET-TDM FDG and innovative Immunohistochemistry parameters.
Measured: 2 years
To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry.
Correlation coefficients between the continuous criteria of the FDG PET texture parameters and those of the Immunohistochemistry.
Measured: 2 years
assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry defined as relevant to 2-year event-free survival
2-year event-free survival rate in multivariate analysis according to standard parameters, PET-TDM FDG imaging parameters and Immunohistochemistry.
Measured: 2 years
Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups
2-year event-free survival rate depending on the risk groups determined from the nomogram score.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start5 Nov 2019
- Primary completion22 Oct 2022
- Study completion22 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline ROUSSEAU, MD, PhD, Principal investigator, caroline.rousseau@ico.unicancer.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226222
- Sponsor's protocol ID
- ICO-2019-03
- Acronym
- FICTION
- Status last verified
- Aug 2022
- First submitted
- 9 Jan 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04226222
- Acronym / sponsor ID
- FICTION / ICO-2019-03
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 22 Oct 2024 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple negative Breast Cancer | – | Diagnostic Test: TEP-TDM FDGTriple Negative Breast Cancer operatable from the outset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with triple negative breast cancer operatable from the outset will be
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEP-TDM FDGSemi-quantitative PET-TDM FDG Data and Texture Analysis | Diagnostic test | Triple negative Breast Cancer |
Primary outcome
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.
4 secondary outcomes
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
To assess the correlations between continuous texture parameters in PET-TDM FDG and Immunohistochemistry.
Time frame: 2 years
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
Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline ROUSSEAU, MD, PhD principal investigator
caroline.rousseau@ico.unicancer.fr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institut Cancerologie de l'Ouest at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years. (time frame: 2 years). 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 21 Feb 2023.