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NCT Number: NCT04273542

Interest of Broadband Spectroscopy Analysis 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Female BRCA1 Mutation BRCA2 Mutation Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean PERRIN, Clermont-Ferrand, Puy de Dome, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid Biopsy

Other

Blood sample collection during follow-up of the three cohorts of patients

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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).

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Collaborators

  • International Cancer Research Group, United Arab Emirates

Registry information

Official study 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

Acronym: ICRG0101

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Feb 18, 2020
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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