Status:
UNKNOWN
Development of a Horizontal Data Integration Classifier for Noninvasive Early Diagnosis of Breast Cancer
Lead Sponsor:
Ospedale Policlinico San Martino
Collaborating Sponsors:
Associazione Italiana per la Ricerca sul Cancro
Universita degli Studi di Genova
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a translational no-profit study. Our proposal aims at creating a noninvasive Horizontal Data Integration (HDI) classifier for early diagnosis of breast cancer, with the final goal of avoiding ...
Detailed Description
Background: Currently, early diagnosis of invasive breast cancer relies on the combined use of mammogram and ultrasound. These approaches are still suboptimal in terms of accuracy, and confirmation bi...
Eligibility Criteria
Inclusion
- Written informed consent
- Breast lesions detected by digital bilateral mammography
- Eligible for diagnostic biopsy (tru-cut or VABB) as per normal clinical practice
- Ability and willfulness to comply with the protocol requirements
Exclusion
- Previous history of cancer, any type
- Clinical or radiological suspicion of advanced or metastatic cancer at the time of screening
- Known history of active or treated autoimmune or manifest chronic or seasonal and active allergic disorders
- History of major trauma or surgery during the 24 weeks before screening
- History of active infectious disease, either chronic or acute but occurring during the 8 weeks before screening
- History of known acute or chronic cardiac, kidney, or liver disease disorders or acute cardiac events
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT04781062
Start Date
January 19 2021
End Date
December 1 2024
Last Update
November 1 2022
Active Locations (1)
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1
Ospedale Policlinico San Martino
Genova, Italy, 16132