Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening
- Conditions
- BRCA2 MutationBreast Cancer FemaleBRCA1 Mutation
- Interventions
- Other: liquid biopsy
- Registration Number
- NCT04273542
- Lead Sponsor
- Centre Jean Perrin
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1100
*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
-
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
-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient cohort liquid biopsy 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 liquid biopsy 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. Control cohort liquid biopsy 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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).
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
Trial Locations
- Locations (8)
Hôpital La Pitié Salpêtrière
🇫🇷Paris, Ile De France, France
Hôpital Saint-Louis
🇫🇷Paris, Ile De France, France
Centre Jean PERRIN
🇫🇷Clermont-Ferrand, Puy De Dome, France
Hôpital Tenon
🇫🇷Paris, Ile De France, France
Pôle Santé République
🇫🇷Clermont-Ferrand, Puy De Dôme, France
Institut de Cancérologie de l'Ouest
🇫🇷Saint Herblain, France
Centre Eugène MARQUIS
🇫🇷Rennes, France
La Chataigneraie (Selimed 63)
🇫🇷Beaumont, Puy De Dôme, France