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

  • STATUS
    Recruiting
  • End date
    May 23, 2027
  • participants needed
    1100
  • sponsor
    Centre Jean Perrin
Updated on 23 April 2022
Accepts healthy volunteers

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.

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.

Details
Condition Breast Cancer Female, BRCA1 Mutation, BRCA2 Mutation
Treatment Liquid Biopsy
Clinical Study IdentifierNCT04273542
SponsorCentre Jean Perrin
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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
Patients with Stage III/IV or Bilateral Breast Cancer
For Control cohort
For Patient cohort
For Exploratory cohort
Concomitant breast cancer
History of breast cancer
Invasive breast cancer suspected at mammography before liquid biopsy
Mammography classified ACR3 or ACR4
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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