Clinical trial · Interventional
Predictive Role of New Biomarkers for Hypersensitive Patients to Radiation in Breast Cancer (BIORISE)
Radiation-induced Late Side-effects: Predictive Role of New Biomarkers for Selecting Hypersensitive Patients to Ionizing Radiation in Breast Cancer (BIORISE)
NCT03252717CI-TRIAL-00087975BIORISEactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To confirm the protein expression level in radiation-induced late effects patients and to determine the performance value, in particular the positive predictive value, of a blood test based on the dosage of a panel of five proteins, it is necessary to validate these preliminary results by a prospective study on a large cohort of patients.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- blood sample
- description
- Pre-treatment blood samples will be collected: 8 samples
- interventionNames
- Biological: Blood sample
Primary outcomes (1)
- measure
- blood sample to assess dosage of 5 proteins
- timeFrame
- through study completion, an average of 5 years
- description
- Confirm the predictive value, of a blood test based on the dosage of a panel of five (5) proteins: AK2 - IDH2 - ANX1- APEX1 - HSC70 in radiation-induced late side effects after breast-conserving surgery and curative intent adjuvant radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients suitable for adjuvant radiotherapy for cancer of the breast (invasive or in situ) including breast patients receiving neo-adjuvant chemotherapy. Patients receiving chemotherapy should have completed their course of chemotherapy (anthracyclines) at least one month prior to radiotherapy commencing. * No other malignancy prior to treatment for the specified tumour types except basal cell or squamous cell carcinoma of the skin * No evidence of distant metastases * Patients able to provide a venous blood sample * Willingness and ability to comply with scheduled visits, treatment plans and available for follow up * Greater than 18 years of age; no upper age limit * The capacity to understand the patient information sheet and the ability to provide written informed consent * Patients must be affiliated to a Social Security System Exclusion Criteria: * Patients with metastatic disease * Prior irradiation at the same site * Planned use of protons * Breast patients receiving concomitant chemo-radiation * Male breast cancer patients * Mastectomy patients * Bilateral breast cancer * Mental disability or patient otherwise unable to give informed consent * Limited life expectancy due to co-morbidity * Pregnant patients * Partial breast irradiation * Patients with breast implants if not removed during surgery
References
Publications (0)
Data not yet available
No reference posted for this study.