Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening (ICRG0101)

September 3, 2025 updated by: Centre Jean Perrin

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Institut de cancerologie de l'ouest
      • Rennes, France
        • Centre Eugene Marquis
      • Saint-Herblain, France
        • Institut de cancerologie de l'ouest
    • Puy de Dome
      • Clermont-Ferrand, Puy de Dome, France, 63011
        • Centre Jean Perrin
    • Puy de Dôme
      • Beaumont, Puy de Dôme, France, 63110
        • La Chataigneraie (Selimed 63)
      • Clermont-Ferrand, Puy de Dôme, France, 63000
        • Pôle Santé République
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75000
        • Hôpital La Pitié Salpêtrière
      • Paris, Île-de-France Region, France, 75010
        • Hopital Saint-Louis
      • Paris, Île-de-France Region, France, 75020
        • Hopital Tenon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Other: liquid biopsy
Blood sample collection during follow-up of the three cohorts of patients
Other: 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.
Other: liquid biopsy
Blood sample collection during follow-up of the three cohorts of patients
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.
Other: liquid biopsy
Blood sample collection during follow-up of the three cohorts of patients

What is the study measuring?

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
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.
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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).
T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Collaborators

International Cancer Research Group, United Arab Emirates

Investigators

  • Principal Investigator: Frédérique PENAULT-LLORCA, Pr, Centre Jean Perrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2021

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00058-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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