Development of a Horizontal Data Integration Classifier for Noninvasive Early Diagnosis of Breast Cancer (RENOVATE)
Breast Cancer

About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Translational Study, Horizontal Data Integration Classifier
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Ospedale Policlinico San Martino
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Breast Cancer Stage T1 Group
Benign Breast Lesion Group
Women with radiologically identified lesions, BIRADS-3/4/5, smaller than 2 cm by radiological assessment (i.e., radiological T1), will be enrolled and invited to donate peripheral blood samples and urine samples at baseline. Radiological images as well as demographic and anatomopathological data will be collected. If bioptically confirmed T1 breast cancer, patients will undergo a second peripheral blood and urine collection after primary breast cancer surgery.
Women with radiologically identified lesions, BIRADS-3/4/5, smaller than 2 cm by radiological assessment (i.e., radiological T1), will be enrolled and invited to donate peripheral blood samples and urine samples at baseline. Radiological images as well as demographic and anatomopathological data will be collected. If bioptically confirmed benign lesion, no other samples will be collected.