Clinical trial · Observational
Validation of a Prognostic Method for Assessing the Risk of Distant Metastasis in Early-stage Breast Cancer
Dissecting the Role of miR-3916 and miR3613-5p in Breast Cancer and Developing a Metastases Predictor PORTENT Algorithm
- 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 multicenter, observational validation study designed to evaluate the prognostic performance of the PORTENT algorithm in patients with early-stage breast cancer. The model integrates clinicopathological variables and the expression levels of two small non-coding RNAs (miR-3916 and miR-3613-5p) to estimate individual risk of developing distant metastases. The primary objective is to assess the discriminatory ability of the PORTENT algorithm for predicting distant metastasis at predefined time points after diagnosis.
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 Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Validation of Prognostic tool | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- CSS Cohort
- description
- 350 stage 1 to 3A patients will be selected from the BREMIR study (ID NCT06555354) prospective cohort.
- interventionNames
- Diagnostic Test: Validation of Prognostic tool
- label
- External Cohort
- description
- The External\_cohort will include patients enrolled retrospectively from the centers participating in the study. A total of at least 450 patients will be selected, with residual tumor tissue available at the respective Pathology Departments. Each center will enroll a minimum of 75 patients, comprising 60 who remain disease-free after at least 5 years of follow-up and 15 who experience metastatic progression after at least 3 years of follow-up.
- interventionNames
- Diagnostic Test: Validation of Prognostic tool
- label
- INT-Milan
- description
- The INT\_Milan cohort includes 300 Luminal A breast cancer cases treated with neoadjuvant therapy, with available pre-treatment and/or surgical residual tumor tissue.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage I-III breast cancer * Residual tumor tissue available * Written informed consent Exclusion Criteria: * Age \<18 * Stage IV at diagnosis * Refusal or inability to provide informed consent
References
Publications (1)
- BACKGROUNDFontana A, Barbano R, Pasculli B, Mazza T, Palumbo O, Binda E, Trivieri N, Mencarelli G, Laurenzana I, Lamorte D, De Luca L, Caivano A, Biagini T, Rendina M, Lo Mele A, Prencipe G, Bravaccini S, Murgo R, Ciuffreda L, Morritti M, Valori VM, Di Lisa FS, Vici P, Castelvetere M, Carella M, Graziano P, Maiello E, Copetti M, Esteller M, Parrella P. Development of a microRNA-based prognostic model for accurate prediction of distant metastasis in breast cancer patients. Breast Cancer Res. 2025 Sep 29;27(1):170. doi: 10.1186/s13058-025-02124-4. PMID 41024243