NCT04273542

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
May 2021May 2029

First Submitted

Initial submission to the registry

February 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

7.9 years

First QC Date

February 14, 2020

Last Update Submit

September 3, 2025

Conditions

Breast Cancer FemaleBRCA1 MutationBRCA2 Mutation

Keywords

Breast cancerbroadband spectroscopy laserliquid biospsiescancer screening

Outcome Measures

Primary Outcomes (1)

  • Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer screening

    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 Outcomes (4)

  • Correlating the results of high-speed laser spectroscopy analysis on liquid biopsies with mammography data (ACR 0-5)

    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

    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

    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

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

Study Arms (3)

Control cohort

OTHER

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

Patient cohort

OTHER

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

Exploratory cohort

OTHER

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

Interventions

liquid biopsyOTHER

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

Control cohortExploratory cohortPatient cohort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \*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:
  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centre Jean PERRIN

Clermont-Ferrand, Puy de Dome, 63011, France

Location

La Chataigneraie (Selimed 63)

Beaumont, Puy de Dôme, 63110, France

Location

Pôle Santé République

Clermont-Ferrand, Puy de Dôme, 63000, France

Location

Institut de Cancérologie de l'Ouest

Angers, France

Location

Centre Eugène MARQUIS

Rennes, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Location

Hôpital La Pitié Salpêtrière

Paris, Île-de-France Region, 75000, France

Location

Hôpital Saint-Louis

Paris, Île-de-France Region, 75010, France

Location

Hôpital Tenon

Paris, Île-de-France Region, 75020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingInvestigative Techniques

Study Officials

  • Frédérique PENAULT-LLORCA, Pr

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 18, 2020

Study Start

May 31, 2021

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)