NCT02999152

Validation of Radio-induced Damage Biomarkers

Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to confirm in humans the relevance and the kinetics of radio-induced bio-markers in plasma and urines, previously described at the preclinical stage.

Detailed description

The nuclear and radiologic risks monitoring is a major preoccupation for our society. During an accident, it is primordial to define the biologic dosimetry. The dose and distribution knowledge is crucial for the medical care. Indeed, Total Body Irradiation (TBI) and Partial Body Irradiation (PBI) do not have the same clinical outcome. A Total Body Irradiation induces an acute radiation syndrome with a Medullary Aplasia. A quick diagnostic would allow the optimization of the medical care. Nowadays, the analyse of the chromosome with two centromeres is the current norm to estimate the radiation dose, but this technique is time consuming, and not adapted to an emergency situation, and to a large population. The new genetic techniques could permit the quick radiation dosimetry diagnosis. The research of early exposition bio-markers seems to be of a major interest. These bio-markers would allow to rapidly define the radiations perceived by an exposed subject, before the apparition of the symptoms, and by the way, to conduct to a therapeutic strategy more adapted to the patient. In this purpose, the present study will need blood and urines samples of patients totally or partially exposed to radiations, according to their usual medical care.

Conditions

• Bone Metastasis
• Malignant Hemopathy

Interventions

Type	Name	Description
OTHER	blood and urines samples	For all patients the blood samples must be organized: Before, 4 hours (+/-30 min), 1 day, 2 days, and 3 days after the start of the radiation therapy. Collections of urine must be organized: Before, 1 day, and 2 days after the radiation therapy.

Timeline

• Start date: 2017-06-22
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2016-12-21
• Last updated: 2022-02-22

Locations

2 sites across 1 country: France