Clinical trial · Interventional
Development of a Horizontal Data Integration Classifier for Noninvasive Early Diagnosis of Breast Cancer
- 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)
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 in most cases useless biopsies of suspect cases encountered during radiological screening. 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 (35 ml) and urine samples (50 ml). Radiological images as well as demographic and anatomopathological data will be collected. Objective of this project is to develop a HDI classifier enabling early noninvasive diagnosis of breast cancer with similar accuracy compared to breast biopsies. Such classifier will be developed based on the correlation between the molecular profile of peripheral blood (ctDNA, proteins, exosomes) and urine (ctDNA) collected at T0 (baseline, before diagnostic biopsy) and bioptic diagnosis. The assessment of the profile of peripheral blood (ctDNA, proteins, exosomes) and urine (ctDNA) at two time points for diagnosed pT1 breast cancers (T0: baseline, before biopsy; T1: after diagnosis of pT1 breast cancer) will allow us to distinguish between tumor- and host-specific molecular alterations in connection with the presence/absence of breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and urine molecular analysis (Timing 0) | Diagnostic Test | — | UNRESOLVED |
| Blood and urine molecular analysis (Timing 1) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breast Cancer Stage T1 Group
- description
- 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.
- interventionNames
- Diagnostic Test: Blood and urine molecular analysis (Timing 0)
- Diagnostic Test: Blood and urine molecular analysis (Timing 1)
- type
- ACTIVE_COMPARATOR
- label
- Benign Breast Lesion Group
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRavera F, Cirmena G, Dameri M, Gallo M, Vellone VG, Fregatti P, Friedman D, Calabrese M, Ballestrero A, Tagliafico A, Ferrando L, Zoppoli G. Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol. BMJ Open. 2021 Dec 31;11(12):e054256. doi: 10.1136/bmjopen-2021-054256. PMID 34972769