Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multicenter Large-scale Validation Study of the Interest of Broadband Spectroscopy Analysis (Femto/Attosecond by Infrared Laser) on Liquid Biopsies in Breast Cancer Screening

Conditions
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Breast Cancer Female, BRCA1 Mutation, BRCA2 Mutation

Intervention / Treatment
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* Other: liquid biopsy


Participation Criteria
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Eligibility Criteria
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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 : Refusal to participate Reluctant or unable to comply with study requirements Pregnant or breastfeeding woman History of breast cancer For Patient cohort - Patients with Stage III/IV or Bilateral Breast Cancer For Control cohort: Invasive breast cancer suspected at mammography before liquid biopsy* Mammography classified ACR3 or ACR4 For Exploratory cohort: Concomitant breast cancer At inclusion visit, woman for whom an invasive breast cancer will be suspected at mammography will be include in Patient cohort after an histological proof of cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control cohort<br>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). | Other: liquid biopsy<br>* Blood sample collection during follow-up of the three cohorts of patients<br>|
| Other: Patient cohort<br>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. | Other: liquid biopsy<br>* Blood sample collection during follow-up of the three cohorts of patients<br>|
| Other: Exploratory cohort<br>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. | Other: liquid biopsy<br>* Blood sample collection during follow-up of the three cohorts of patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, broadband spectroscopy laser, liquid biospsies, cancer screening