Diagnostic Prediction Model for De Novo Metastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMarkusovszky University Teaching Hospital os County Vas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
A consecutive cohort of adult female patients with newly diagnosed invasive breast cancer.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
925 Participants
are grouped into 1 trial groupGroup A: Primary study cohort
Trial outcomes
Primary outcomes
1
De novo metastatic breast cancer
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.
Time frame
From the initial diagnostic mammogram up to 12 months of follow-up.Secondary outcomes
1
Incidence of rapid metastatic recurrence
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.
Time frame
Up to 12 months from the initial diagnostic mammogram.2
Systemic staging interval
The time elapsed from the initial diagnostic mammogram to the completion of baseline systemic staging.
Time frame
Up to 12 months from the initial diagnostic mammogram.3
Diagnostic interval
The time elapsed from the initial diagnostic mammogram to the confirmation of macroscopic distant metastasis.
Time frame
Up to 12 months from the initial diagnostic mammogram.Sponsors and contacts
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Source ClinicalTrials.gov