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

Breast Cancer Female Clinical Trial

— ICRG0101  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04273542
• Other study ID #: 2020-A00058-31
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: May 2029

Study information

• Verified date: November 2023
• Source: Centre Jean Perrin
• Contact: Angeline GINZAC, PhD
• Phone: 0463663337
• Email: angeline.ginzac[@]clermont.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• liquid biopsy
Blood sample collection during follow-up of the three cohorts of patients

Locations

Country	Name	City	State
France	La Chataigneraie (Selimed 63)	Beaumont	Puy De Dôme
France	Centre Jean PERRIN	Clermont-Ferrand	Puy De Dome
France	Pôle Santé République	Clermont-Ferrand	Puy De Dôme
France	Hôpital La Pitié Salpêtrière	Paris	Ile De France
France	Hôpital Saint-Louis	Paris	Ile De France
France	Hôpital Tenon	Paris	Ile De France

Sponsors (3)

Lead Sponsor	Collaborator
Centre Jean Perrin	Institut Max Planck d'optique quantique, International Cancer Research Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlating the results of high-speed laser spectroscopy analysis on liquid biopsies with mammography data (ACR 0-5)	The results of high-speed laser spectroscopy analysis on liquid biopsies will be correlated with mammography data	T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
Secondary	Estimate detection rate of both breast cancer screening methods (spectroscopy/mammography) for control cohort	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	T0 : inclusion; T2 : +2 years; T4: +4years
Secondary	To study the role of confounding factors in the structure of molecular profiles derived from broadband laser spectroscopy	To study the confounding role of hormonal status and concomitant inflammatory states in the structure of molecular profiles derived from broadband laser spectroscopy	T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
Secondary	Comparison of BRCA1/2 patients molecular profiles with control and patient cohorts derived from broadband laser spectroscopy	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).	T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years