Clinical trial NCT04273542: Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening
Official title: Multicenter Large-scale Validation Study of the Interest of Broadband Spectroscopy Analysis (Femto/Attosecond by Infrared Laser) on Liquid Biopsies in Breast Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
BRCA1 Mutation
BRCA2 Mutation
Keywords: Breast cancer
broadband spectroscopy laser
liquid biospsies
cancer screening
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: International Cancer Research Group
name: Institut Max Planck d'optique quantique
First posted: 2020-02-18
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer screening
timeFrame: Comparison between the different cohorts at (T0 : inclusion) and the others visits (T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years)
Secondary outcomes:
measure: Correlating the results of high-speed laser spectroscopy analysis on liquid biopsies with mammography data (ACR 0-5)
timeFrame: T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
measure: Estimate detection rate of both breast cancer screening methods (spectroscopy/mammography) for control cohort
timeFrame: T0 : inclusion; T2 : +2 years; T4: +4years
measure: To study the role of confounding factors in the structure of molecular profiles derived from broadband laser spectroscopy
timeFrame: T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
measure: Comparison of BRCA1/2 patients molecular profiles with control and patient cohorts derived from broadband laser spectroscopy
timeFrame: T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
state: Ile De France
city: Paris
country: France
facility: Hôpital Saint-Louis
state: Ile De France
city: Paris
country: France
facility: Hôpital Tenon
state: Ile De France
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
state: Puy De Dome
city: Beaumont
country: France
facility: La Chataigneraie (Selimed 63)
state: Puy De Dôme
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
state: Puy De Dôme
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Rennes
country: France
facility: Centre Eugène MARQUIS
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
Study officials:
affiliation: Centre Jean Perrin
name: Frédérique PENAULT-LLORCA, Pr
role: PRINCIPAL_INVESTIGATOR
References: