Status:
ACTIVE_NOT_RECRUITING
Predictive Role of New Biomarkers for Hypersensitive Patients to Radiation in Breast Cancer (BIORISE)
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 dos...
Detailed Description
Molecular mechanisms involved in radiation-induced responses are complex, and proteomic approaches can be used to better understand the overall reaction process of ionizing radiation and to identify p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03252717
Start Date
August 1 2014
Last Update
April 2 2025
Active Locations (1)
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1
Institut régional du Cancer de Montpellier
Montpellier, France, 34298