Multicenter Large-scale Validation Study of the Interest of Broadband Spectroscopy Analysis (Femto/Attosecond by Infrared Laser) on Liquid Biopsies in Breast Cancer Screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,100
- Locations
- 16
- Primary Endpoint
- Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer screening
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Patient cohort
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.
Intervention: liquid biopsy (Other)
Exploratory cohort
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.
Intervention: liquid biopsy (Other)
Control cohort
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).
Intervention: liquid biopsy (Other)
Outcomes
Primary Outcomes
Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer screening
Time Frame: 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 Outcomes
- 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)
- 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)
- Estimate detection rate of both breast cancer screening methods (spectroscopy/mammography) for control cohort(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(T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years)