Clinical trial NCT02999152: Validation of Radio-induced Damage Biomarkers
Official title: Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bone Metastasis
Malignant Hemopathy
Keywords: Bio-markers
Radiation
Appropriate therapeutic strategy
Total Body Irradiation
Partial Body Irradiation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Institut de Recherche Biomedicale des Armees
name: Institut de Cancérologie de la Loire
First posted: 2016-12-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of haematological and biochemical markers
timeFrame: Day 3
measure: Quantification of chromosomal aberrations
timeFrame: Day 3
measure: Detection of biochemical markers
timeFrame: Day 3
measure: Metabolomics markers levels
timeFrame: Day 2
Secondary outcomes:
measure: Total dose of radiation
timeFrame: Day 3
measure: Radiation field
timeFrame: Day 3
Other outcomes:
Locations:
city: Saint-Priest en Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Nicolas Magné, PhD
role: PRINCIPAL_INVESTIGATOR
References: