BRCA1 Mutation, BRCA2 Mutation, Breast Cancer Female
Conditions
Keywords
Breast cancer, broadband spectroscopy laser, liquid biospsies, cancer screening
Brief summary
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
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.
Interventions
OTHERliquid biopsy
Blood sample collection during follow-up of the three cohorts of patients
Sponsors
International Cancer Research Group, United Arab Emirates
Centre Jean Perrin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer screening | Comparison between the different cohorts at (T0 : inclusion) and the others visits (T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlating the results of high-speed laser spectroscopy analysis on liquid biopsies with mammography data (ACR 0-5) | T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years | The results of high-speed laser spectroscopy analysis on liquid biopsies will be correlated with mammography data |
| Estimate detection rate of both breast cancer screening methods (spectroscopy/mammography) for control cohort | T0 : inclusion; T2 : +2 years; T4: +4years | 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 |
| To study the role of confounding factors in the structure of molecular profiles derived from broadband laser spectroscopy | T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years | To study the confounding role of hormonal status and concomitant inflammatory states in the structure of molecular profiles derived from broadband laser spectroscopy |
| Comparison of BRCA1/2 patients molecular profiles with control and patient cohorts derived from broadband laser spectroscopy | T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years | 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). |
Countries
France
Outcome results
None listed