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

NCT03252717 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-04-02

No results posted yet for this study

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

Interventions

BIOLOGICAL

Blood sample

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

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • david azria · Institut régional du Cancer de Montpellier

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03252717 on ClinicalTrials.gov