Diagnostic Prediction Model for De Novo Metastatic Breast Cancer

NCT07752238 | Not Yet Recruiting

• 1 other identifier: VAS-RKEB/BNJ-6/2026
• Study Type: observational
• Target: 925
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer; Metastatic Invasive Breast Cancer

Keywords

de novo metastasis; breast cancer; predictive modelling

Outcome Measures

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.

  From the initial diagnostic mammogram up to 12 months of follow-up.

Secondary Outcomes (3)

• Incidence of rapid metastatic recurrence

  Up to 12 months from the initial diagnostic mammogram.

• Systemic staging interval

  Up to 12 months from the initial diagnostic mammogram.

• Diagnostic interval

  Up to 12 months from the initial diagnostic mammogram.

Study Arms (1)

Primary study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Female sex, aged 18 years or older.
• Newly diagnosed invasive breast cancer.
• 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.

You may not qualify if:

• Absence of baseline systemic staging.

Sponsors & Collaborators

• Markusovszky University Teaching Hospital os County Vas: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Oliver L Stari, MD

CONTACT

011-36-94-311542; stari.oliver@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.