Predictive Role of New Biomarkers for Hypersensitive Patients to Radiation in Breast Cancer (BIORISE)

NCT03252717 | Active Not Recruiting

• 1 other identifier: ICM-URC-2014/22
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• blood sample to assess dosage of 5 proteins

  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.

  through study completion, an average of 5 years

Study Arms (1)

blood sample

EXPERIMENTAL

Pre-treatment blood samples will be collected: 8 samples

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

Pre-treatment blood samples will be collected for downstream analyses: * Three 6 ml EDTA samples for proteomic and genomic work package * One 6 ml dry sample for auto-antibodies analysis in the immunology work package * Two 4 ml EDTA samples for DNA extraction in the immunology work package * Two 2.5 ml PAX Gene sample for RNA extraction in the immunology work package and the non-irradiated control in the genomic work package

blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• david azria

  Institut régional du Cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: August 17, 2017
• Study Start: August 1, 2014
• Primary Completion: August 31, 2017
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)