Breast CancerMoSi4BCaNCT05724407
Molecular Signature for Breast Cancer
An observational study of Breast Cancer, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diagnostic assistance tool
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Female breast cancer patient
Who may be able to join
- Patients over 18 years of age
- Understanding French
- With symptoms of breast cancer that required a biopsy (microbiopsy or macrobiopsy or surgical biopsy) and pathological examination diagnosing breast cancer
- First diagnosis of invasive breast cancercarcinoma
- Affiliated to a social security system
- Agreeing to participate in the study
Who cannot join
- Refusal to participate in the study
- Not affiliated to the social security system
- Minor or under legal protection
- Patient with a history of breast cancer
- Patient previously treated for breast cancer
- Patient who has relapsed from breast cancer treatment
- Non ductal or non lobular invasive breast cancer carcinoma
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer
The main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating an automatic analysis algorithm compared to a reference (gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care) in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard.
- Conditions
- Breast Cancer
- Being tested
- Diagnostic assistance tool
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic assistance toolOther
Diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor).
Each anatomo-histopathological slide will be re-read 3 times:
- Reading 1: first reading by a pathologist in the care setting
- Reading via the standard care procedure (microscope and physical slides)
- Reading 2: Second reading by another pathologist from the same center, as part of the research.
- Reading via the standard procedure of care (microscope and physical slides)
- Reading 3: Third reading by the initial physician, with the algorithmic tool MoSi4BCa after digitization of the slides by a laboratory technician and after a wash-out period of 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Female patient diagnosed for breast cancer Receives: Other: Diagnostic assistance tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performances
The diagnostic performance of the automatic marker scoring support tool will be assessed based on the pathologists' gold standard using sensitivity and specificity
Measured: at inclusion
Secondary outcomes (6)
Duration of procedure
Comparison of medical time spent reading the slide and establishing marker identification between the standard of care method (microscope and pathologist alone) and the automatic marker scoring support tool (MoSi4BCa)
Measured: at inclusion
Cognitive savings
The contribution of the tool in terms of cognitive savings will be evaluated using quantitative survey for the pathologists participating in the study.
Measured: at inclusion
General comfort of use
The contribution of the tool in terms of general comfort of use will be evaluated using quantitative survey for the pathologists participating in the study.
Measured: at inclusion
Organizational constraints
The organizational constraints of the integration of the solution will be evaluated using a specific questionnaire dedicated to the pathologists and laboratory technicians who participated in the implementation and preparation of the installations.
Measured: at inclusion
inter-rater agreement
Agreement between pathologists will be assessed using using Kappa coefficient or intraclass correlation coefficient
Measured: at inclusion
Diagnostic performances
Diagnostic performances will be assessed using positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value, and C-index or Area Under the Curve
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724407
- Sponsor's protocol ID
- APHP211593
- Acronym
- MoSi4BCa
- Status last verified
- Jan 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of a Diagnostic Assistance Tool of Prognostic and Predictive Marker Scoring System in Breast Cancer
- ClinicalTrials.gov ID
- NCT05724407
- Acronym / sponsor ID
- MoSi4BCa / APHP211593
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Feb 2023 (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 main objective of this study is to evaluate and compare the diagnostic performance of a diagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor) integrating an automatic analysis algorithm compared to a reference (gold standard defined as the rereading by at least two different anatomopathologists according to the standard method of care) in order to show the non-inferiority of the automatic analysis algorithm compared to this gold standard.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care | – | Other: Diagnostic assistance toolFemale patient diagnosed for breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female breast cancer patient
Key inclusion criteria (6 listed)
- Patients over 18 years of age
- Understanding French
- With symptoms of breast cancer that required a biopsy (microbiopsy or macrobiopsy or surgical biopsy) and pathological examination diagnosing breast cancer
- First diagnosis of invasive breast cancercarcinoma
- Affiliated to a social security system
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- Not affiliated to the social security system
- Minor or under legal protection
- Patient with a history of breast cancer
- Patient previously treated for breast cancer
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 |
|---|---|---|
| Diagnostic assistance toolDiagnostic assistance tool for analysis of 5 prognostic and predictive markers of breast cancer (HER2, Ki67 Index, Mitoses, Estrogen Hormone Receptor, Hormone Progesteron receptors hormone of Progesteronereceptor). Each anatomo-histopathological slide will be re-read 3 times: * Reading 1: first reading by a pathologist in the care setting * Reading via the standard care procedure (microscope and physical slides) * Reading 2: Second reading by another pathologist from the same center, as part of the research. * Reading via the standard procedure of care (microscope and physical slides) * Reading 3: Third reading by the initial physician, with the algorithmic tool MoSi4BCa after digitization of the slides by a laboratory technician and after a wash-out period of 2 months. | Other | Standard of care |
Primary outcome
Diagnostic performances
Time frame: at inclusion
The diagnostic performance of the automatic marker scoring support tool will be assessed based on the pathologists' gold standard using sensitivity and specificity
6 secondary outcomes
Duration of procedure
Time frame: at inclusion
Cognitive savings
Time frame: at inclusion
General comfort of use
Time frame: at inclusion
Organizational constraints
Time frame: at inclusion
inter-rater agreement
Time frame: at inclusion
Diagnostic performances
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assistance Publique - Hôpitaux de Paris.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Bertheau (+3342494135, philipppe.bertheau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performances (time frame: at inclusion). 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 13 Feb 2023.