Breast Cancer FemaleICRG0101NCT04273542
Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening
A study testing liquid biopsy in people with Breast Cancer Female and BRCA1 Mutation, run by Centre Jean Perrin at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, BRCA1 Mutation, BRCA2 Mutation
- What is being tested?
- liquid biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 9 sitesFrance
- Study dates
- 31 May 2021to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Institut de Cancérologie de l'Ouest
Angers
La Chataigneraie (Selimed 63)
Beaumont, Puy de Dôme, 63110
Centre Jean PERRIN
Clermont-Ferrand, Puy de Dome, 63011
Pôle Santé République
Clermont-Ferrand, Puy de Dôme, 63000
Hôpital La Pitié Salpêtrière
Paris, Île-de-France Region, 75000
Hôpital Saint-Louis
Paris, Île-de-France Region, 75010
Hôpital Tenon
Paris, Île-de-France Region, 75020
Centre Eugène MARQUIS
Rennes
Institut de Cancérologie de l'Ouest
Saint-Herblain
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer Female, BRCA1 Mutation, BRCA2 Mutation
- Being tested
- liquid biopsy
- Keywords
- Breast cancer, broadband spectroscopy laser, liquid biospsies, cancer screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid biopsyOther
Blood sample collection during follow-up of the three cohorts of patients
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Other: liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The results of high-speed laser spectroscopy analysis on liquid biopsies will be correlated with mammography data
Measured: 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
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
Measured: 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
To study the confounding role of hormonal status and concomitant inflammatory states in the structure of molecular profiles derived from broadband laser spectroscopy
Measured: 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
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).
Measured: T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start31 May 2021
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- International Cancer Research Group, United Arab Emirates
- Responsible party
- Sponsor
- Investigators
- Frédérique PENAULT-LLORCA, Pr, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273542
- Sponsor's protocol ID
- 2020-A00058-31
- Acronym
- ICRG0101
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2020
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04273542
- Acronym / sponsor ID
- ICRG0101 / 2020-A00058-31
- Conditions
- Breast Cancer Female, BRCA1 Mutation, BRCA2 Mutation
- Keywords
- Breast cancer, broadband spectroscopy laser, liquid biospsies, cancer screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- International Cancer Research Group, United Arab Emirates
- Study start
- 31 May 2021 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control cohort | Other | Other: liquid biopsyIn 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). |
| Patient cohort | Other | Other: liquid biopsyIn 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. |
| Exploratory cohort | Other | Other: liquid biopsyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult woman capable of giving informed consent to research participation
- Affiliation to the French social security system
- Woman participating in organised screening or benefiting from individual follow-up, eligible as such for a mammogram
- woman with invasive breast cancer T0N1, T1N0-1, T2N0-1 (histologically proven) at inclusion and before any cancer treatment
- woman carrying the BRCA1/2 mutation, followed according to standard recommendations or
Key exclusion criteria (13 listed)
- For all participants :
- For Patient cohort
- For Control cohort:
- For Exploratory cohort:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liquid biopsyBlood sample collection during follow-up of the three cohorts of patients | Other | Control cohort, Exploratory cohort, Patient cohort |
Primary outcome
Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer 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)
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.
4 secondary outcomes
Correlating the results of high-speed laser spectroscopy analysis on liquid biopsies with mammography data (ACR 0-5)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: T0: inclusion; T1:+1year; T2: +2years; T3 : +3years; T4:+4years; T5: 5years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédérique PENAULT-LLORCA, Pr principal investigator
Centre Jean Perrin
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liquid biopsy in people with Breast Cancer Female and BRCA1 Mutation, run by Centre Jean Perrin at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the value of molecular profiling analysis in broadband laser spectroscopy on liquid biopsies for breast cancer 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.