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| Name | Class |
|---|---|
| International Cancer Research Group, United Arab Emirates | OTHER |
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The purpose of this study is to validate the interest of broadband spectroscopy analysis (femto/attosecond by infrared laser) on liquid biopsies in breast cancer screening.
Each patient will have one or more liquid biopsy during the follow-up according to the cohort and have a mammogram at the same time.
Biopsies will be analysed by broadband spectroscopy in order to compare the results to mammogram result.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control cohort | Other | In this cohort, women recruited participated to organised breast cancer screening. They must not have an invasive breast cancer. They will have 3 liquid biopsy : the first at inclusion and then at each mammogram every two years (organised breast cancer screening). |
|
| Patient cohort | Other | In this cohort, women for who an invasive breast cancer has been diagnose will be included. Only one liquid biopsy will be collected before any treatment. |
|
| Exploratory cohort | Other | In this cohort, women with high risk of BRCA1/2 mutation but without invasive breast cancer. 6 liquid biopsies will be collected : each year after inclusion during 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liquid biopsy | Other | Blood sample collection during follow-up of the three cohorts of patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer screening | To validate the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for invasive breast cancer screening by comparing a cohort of patients with localized invasive breast cancer (Stage I/II) to a cohort of women without invasive breast cancer from organized or individual age-matched screening. | Comparison between the different cohorts at (T0 : inclusion) and the others visits (T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlating the results of high-speed laser spectroscopy analysis on liquid biopsies with mammography data (ACR 0-5) | The results of high-speed laser spectroscopy analysis on liquid biopsies will be correlated with mammography data | T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years |
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Inclusion Criteria:
*For all participants :
Adult woman capable of giving informed consent to research participation
Affiliation to the French social security system
>For Control cohort:
Woman participating in organised screening or benefiting from individual follow-up, eligible as such for a mammogram
>For Patient cohort:
woman with invasive breast cancer T0N1, T1N0-1, T2N0-1 (histologically proven) at inclusion and before any cancer treatment
>For Exploratory cohort:
woman carrying the BRCA1/2 mutation, followed according to standard recommendations or
woman carrying the BRCA1/2 mutation suffering from in situ BC discovered on biopsy and histologically confirmed
Exclusion Criteria:
For all participants :
For Patient cohort
- Patients with Stage III/IV or Bilateral Breast Cancer
For Control cohort:
For Exploratory cohort:
Concomitant breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Frédérique PENAULT-LLORCA, Pr | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean PERRIN | Clermont-Ferrand | Puy de Dome | 63011 | France | ||
| La Chataigneraie (Selimed 63) |
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| Estimate detection rate of both breast cancer screening methods (spectroscopy/mammography) for control cohort |
Estimate the rate of detection of invasive breast cancer occurring within 5 years of examination in the control group according to the reference method (mammography) and the innovative method ("n-variable molecular profiles") from the baseline analysis performed at Max Planck Institute and algorithmic analysis |
| T0 : inclusion; T2 : +2 years; T4: +4years |
| To study the role of confounding factors in the structure of molecular profiles derived from broadband laser spectroscopy | To study the confounding role of hormonal status and concomitant inflammatory states in the structure of molecular profiles derived from broadband laser spectroscopy | T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years |
| Comparison of BRCA1/2 patients molecular profiles with control and patient cohorts derived from broadband laser spectroscopy | To study the molecular profiles derived from broadband laser spectroscopy on liquid biopsies in a cohort of high-risk women (BRCA1/2) not carrying invasive breast cancer, and to compare their positioning in relation to the 2 main cohorts of the study (patients carrying invasive breast cancer without mutation and controls without invasive breast cancer). | T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years |
| Beaumont |
| Puy de Dôme |
| 63110 |
| France |
| Pôle Santé République | Clermont-Ferrand | Puy de Dôme | 63000 | France |
| Institut de Cancérologie de l'Ouest | Angers | France |
| Centre Eugène MARQUIS | Rennes | France |
| Institut de Cancérologie de l'Ouest | Saint-Herblain | France |
| Hôpital La Pitié Salpêtrière | Paris | Île-de-France Region | 75000 | France |
| Hôpital Saint-Louis | Paris | Île-de-France Region | 75010 | France |
| Hôpital Tenon | Paris | Île-de-France Region | 75020 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000073890 | Liquid Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |
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