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

Primary Purpose

Breast Cancer Female, BRCA1 Mutation, BRCA2 Mutation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
liquid biopsy
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer Female focused on measuring Breast cancer, broadband spectroscopy laser, liquid biospsies, cancer screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Hôpital La Pitié SalpêtrièreRecruiting
  • Hôpital Saint-Louis
  • Hôpital TenonRecruiting
  • Centre Jean PERRINRecruiting
  • La Chataigneraie (Selimed 63)Recruiting
  • Pôle Santé RépubliqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Control cohort

Patient cohort

Exploratory cohort

Arm 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).

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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).

Full Information

First Posted
February 14, 2020
Last Updated
March 24, 2022
Sponsor
Centre Jean Perrin
Collaborators
International Cancer Research Group, Institut Max Planck d'optique quantique
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1. Study Identification

Unique Protocol Identification Number
NCT04273542
Brief Title
Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
Collaborators
International Cancer Research Group, Institut Max Planck d'optique quantique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, BRCA1 Mutation, BRCA2 Mutation
Keywords
Breast cancer, broadband spectroscopy laser, liquid biospsies, cancer screening

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control cohort
Arm Type
Other
Arm 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).
Arm Title
Patient cohort
Arm Type
Other
Arm 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.
Arm Title
Exploratory cohort
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
liquid biopsy
Intervention Description
Blood sample collection during follow-up of the three cohorts of patients
Primary Outcome Measure Information:
Title
Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer screening
Description
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.
Time Frame
Comparison between the different cohorts at (T0 : inclusion) and the others visits (T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years)
Secondary Outcome Measure Information:
Title
Correlating the results of high-speed laser spectroscopy analysis on liquid biopsies with mammography data (ACR 0-5)
Description
The results of high-speed laser spectroscopy analysis on liquid biopsies will be correlated with mammography data
Time Frame
T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
Title
Estimate detection rate of both breast cancer screening methods (spectroscopy/mammography) for control cohort
Description
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
Time Frame
T0 : inclusion; T2 : +2 years; T4: +4years
Title
To study the role of confounding factors in the structure of molecular profiles derived from broadband laser spectroscopy
Description
To study the confounding role of hormonal status and concomitant inflammatory states in the structure of molecular profiles derived from broadband laser spectroscopy
Time Frame
T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
Title
Comparison of BRCA1/2 patients molecular profiles with control and patient cohorts derived from broadband laser spectroscopy
Description
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).
Time Frame
T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angeline GINZAC, PhD
Phone
0463663337
Ext
+33
Email
angeline.ginzac@clermont.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie THIVAT, PhD
Phone
0473278029
Ext
+33
Email
emilie.thivat@clermont.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédérique PENAULT-LLORCA, Pr
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital La Pitié Salpêtrière
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe SPANO, Md, PhD
First Name & Middle Initial & Last Name & Degree
Jean-Philippe SPANO, Md, PhD
Facility Name
Hôpital Saint-Louis
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis TEIXEIRA, Pr
First Name & Middle Initial & Last Name & Degree
Luis TEIXEIRA, Pr
Facility Name
Hôpital Tenon
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph GLIGOROV, MD, PhD
First Name & Middle Initial & Last Name & Degree
Joseph GLIGOROV, MD, PhD
Facility Name
Centre Jean PERRIN
City
Clermont-Ferrand
State/Province
Puy De Dome
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angeline GINZAC, PhD
Phone
0463663337
Ext
+33
Email
angeline.ginzac@clermont.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Frédérique PENAULT-LLORCA, Pr
Facility Name
La Chataigneraie (Selimed 63)
City
Beaumont
State/Province
Puy De Dôme
ZIP/Postal Code
63110
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno De FRAISSINETTE, MD
First Name & Middle Initial & Last Name & Degree
Bruno De FRAISSINETTE, MD
Facility Name
Pôle Santé République
City
Clermont-Ferrand
State/Province
Puy De Dôme
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit MEUSUROLLE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Benoit MEUSUROLLE, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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