Clinical trial · Observational
Diagnostic Prediction Model for De Novo Metastatic Breast Cancer
Development of a Diagnostic Prediction Model for de Novo Metastatic Breast Cancer Using Routinely Available Baseline Parameters
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Invasive Breast Cancer | Invasive Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Primary study cohort
Primary outcomes (1)
- measure
- De novo metastatic breast cancer
- timeFrame
- From the initial diagnostic mammogram up to 12 months of follow-up.
- description
- 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.
Secondary outcomes (3)
- measure
- Incidence of rapid metastatic recurrence
- timeFrame
- Up to 12 months from the initial diagnostic mammogram.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available