Validation of Radio-induced Damage Biomarkers (BIOM-DRI)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Malignant Hemopathy; Bone Metastasis

Treatments: Other: blood and urines samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02999152

2016-A01446-45 (Other Identifier)

2016-0901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• More than 18 years old
• For the group A:

Patient suffering from a malignant blood disease requiring a whole-body radiation, without (or prior to) a concomitant chemotherapy, according to the following protocol: 2x2 Gray per day, during 3 days.

• OR For the group B:

Patient with one (or more) pelvis metastasis requiring radiation therapy without concomitant chemotherapy, according to the following protocol: 4 Gray per day for 5 days.

Exclusion criteria

• More than 70 years old,
• Subject presenting abnormal blood count (grade 3),
• Person with a not controlled chronic illness,
• Subject presenting an abnormal hepatic assessment (grade 3),
• Subject having already received ionizing treatments,
• Subject reached HIV, hepatitis C or any other progressive infectious diseases,
• Pregnant women or nursing mothers,
• Person under protection of justice or unable to give consent.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Total Body Irradiation

Experimental group

Description:

Patient suffering from a malignant blood disease that requires a total body radiation, without (or prior to) a concomitant chemotherapy, according to the following protocol: 2x2 Gray per day, for 3 days. Blood and urines samples will be performed at days 0, 1, 2 and 3 of the treatment plan.

Treatment:

Other: blood and urines samples

Partial Body Irradiation

Experimental group

Description:

Patient with at least one bone metastasis localized at the pelvis and requiring partial body radiation therapy without associated chemotherapy, according to the following protocol: 4 Gray per day for 5 days will perform blood and urines samples at days 0, 1, 2 and 3 after the beginning of the radiation treatment.

Treatment:

Other: blood and urines samples