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

Centre Jean Perrin

Status: Active, not recruiting

Conditions: Breast Cancer Female; BRCA2 Mutation; BRCA1 Mutation

Treatments: Other: liquid biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04273542

2020-A00058-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 3 patient groups

Control cohort

Other group

Description:

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).

Treatment:

Other: liquid biopsy

Patient cohort

Other group

Description:

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.

Treatment:

Other: liquid biopsy

Exploratory cohort

Other group

Description:

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.

Treatment:

Other: liquid biopsy