Diagnostic Prediction Model for De Novo Metastatic Breast Cancer

August 10, 2026 updated by: Oliver Laszlo Stari, Markusovszky University Teaching Hospital os County Vas

Development of a Diagnostic Prediction Model for de Novo Metastatic Breast Cancer Using Routinely Available Baseline Parameters

The goal of this observational study is to create a tool to estimate the risk of macroscopic distant tumor spread in women with newly diagnosed breast cancer. The main question it aims to answer is:

• Can a model, which combines routine medical information collected at diagnosis, accurately predict if a patient has metastasis large enough to be found during systemic imaging? Researchers will review the past medical records of participants who were treated at a university hospital. Because this study looks at past data, participants will not be asked to do any new tasks, take new tests, or change their medical care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

BACKGROUND AND RATIONALE

Baseline risk assessment traditionally relies on anatomical extent, while intrinsic tumour aggressiveness is established as a key determinant of distant spread. In addition, the systemic inflammatory response is increasingly recognized as a driver of tumour progression. The evaluation of these diverse and often conflicting factors complicates early clinical decision-making.

OBJECTIVE

The objective of this study is to develop and internally validate a multivariable diagnostic prediction model using routinely available baseline parameters to estimate the individualised probability of macroscopic distant metastasis among patients with newly diagnosed invasive breast cancer.

STUDY DESIGN AND SETTING

This is an investigator-initiated, single-centre, retrospective cohort study adhering to the TRIPOD+AI statement. The study is conducted at a university teaching hospital, where comprehensive baseline systemic staging is the institutional standard for all newly diagnosed breast cancer patients.

PREDICTORS

The model integrates routinely available baseline parameters: clinical tumor size, clinical lymphnode status, the Ki-67 proliferation marker, and a composite systemic inflammatory marker (Pan-immune-inflammation value).

DATA COLLECTION AND QUALITY ASSURANCE

Data extraction is performed independently by two multidisciplinary teams. Any discrepancies are resolved through a formal adjudication process by an expert panel not involved in data collection (senior oncologist, radiologist, pathologist, and surgeon).

SAMPLE SIZE AND MISSING DATA Based on the criteria proposed by Riley et al., the study requires a minimum of 925 participants and 93 events to accommodate maximum model complexity. Missing data will be handled using complete-case analysis if the rate is <5%, or multiple imputation if >5%.

STATISTICAL ANALYSIS AND MODEL DEVELOPMENT

For the multivariable logistic regression model, all pre-specified predictors are entered simultaneously. Continuous variables are retained in their continuous form. Non-linear relationships modeled using restricted cubic splines. Model performance is evaluated via discrimination and calibration metrics, while clinical utility is assessed through decision curve analysis. Internal validation is conducted using bootstrapping. To correct for model optimism, a global shrinkage factor based on the bootstrap calibration slope is applied. Instability plots are used to illustrate the stability of predictions, calibration, and net benefit.

PATIENT AND PUBLIC INVOLVEMENT (PPI)

To initiate Patient and Public Involvement, an inaugural patient engagement event will be held to discuss the clinical acceptability of a diagnostic prediction model and its potential role in shared decision-making. This event will serve as the foundation to establish a voluntary Patient Advisory Group (PAG). In subsequent project stages, the newly formed PAG will collaborate to co-produce a Plain Language Summary and explore potential pathways for the tool's future clinical application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
925

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hungary
    • Vas County
      • Szombathely, Vas County, Hungary, 9700
        • Recruiting
        • Markusovszky University Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A consecutive cohort of adult female patients with newly diagnosed invasive breast cancer.

Description

Inclusion Criteria:

  • Female sex, aged 18 years or older.
  • Newly diagnosed invasive breast cancer.
  • Case reviewed by the Multidisciplinary Tumour Board at the study site during the inclusion period (between October 1, 2018, and July 31, 2025).
  • No history of prior or synchronous invasive malignancies, except for synchronous bilateral breast cancer.
  • Intent for primary treatment and clinical management at the study site.
  • Availability of longitudinal clinical records throughout the 12-month follow-up period or until death.

Exclusion Criteria:

-Absence of baseline systemic staging.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Primary study cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
De novo metastatic breast cancer
Time Frame: From the initial diagnostic mammogram up to 12 months of follow-up.
A newly diagnosed breast cancer with distant spread identified at baseline systemic staging. Distant lesions are categorized as de novo metastasis if confirmed via biopsy, secondary imaging, follow-up imaging, or Multidisciplinary Tumor Board consensus based on definitive clinical evidence. Equivocal cases are adjudicated through a review of the 12 month clinical follow-up.
From the initial diagnostic mammogram up to 12 months of follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of rapid metastatic recurrence
Time Frame: Up to 12 months from the initial diagnostic mammogram.
Patients developing systemic spread within the 12-month follow-up period, subsequent to an initially negative baseline systemic staging. Patients with rapid metastatic recurrence are excluded from the multivariable analysis and reported descriptively.
Up to 12 months from the initial diagnostic mammogram.
Systemic staging interval
Time Frame: Up to 12 months from the initial diagnostic mammogram.
The time elapsed from the initial diagnostic mammogram to the completion of baseline systemic staging.
Up to 12 months from the initial diagnostic mammogram.
Diagnostic interval
Time Frame: Up to 12 months from the initial diagnostic mammogram.
The time elapsed from the initial diagnostic mammogram to the confirmation of macroscopic distant metastasis.
Up to 12 months from the initial diagnostic mammogram.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Markusovszky University Teaching Hospital os County Vas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VAS-RKEB/BNJ-6/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A complete, cleaned, and de-identified copy of the final dataset will be shared. Sensitive data types, including digital images, specific event dates, and demographic details other than categorical age groups, will be redacted.

IPD Sharing Time Frame

Data will become available upon the publication of the study results and will remain accessible in a restricted-access repository for a period of 5 years.

IPD Sharing Access Criteria

Access will be granted to qualified researchers who submit a methodologically sound proposal for multicenter collaboration, external validation, further research, or independent verification of the results. Data access requests must be submitted through the repository's access management portal, and researchers will be required to sign a Data Use Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings