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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2029-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Cancer Female BRCA1 Mutation BRCA2 Mutation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

liquid biopsy

Intervention Type OTHER

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

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.

Group Type OTHER

liquid biopsy

Intervention Type OTHER

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

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.

Group Type OTHER

liquid biopsy

Intervention Type OTHER

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

Interventions

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liquid biopsy

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes