Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01446-45 | Other Identifier | ANSM |
Not provided
Not provided
Low rythm of inclusions, financial support terminated
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut de Recherche Biomedicale des Armees | OTHER_GOV |
| Institut de Cancérologie de la Loire | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Body Irradiation | Experimental | 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. |
|
| Partial Body Irradiation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood and urines samples | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of haematological and biochemical markers | The following bio-markers levels will be calculated :
| Day 3 |
| Quantification of chromosomal aberrations | Quantification of chromosomal aberrations will be performed on the blood samples performed at days 0, 1, 2 and 3 after the beginning of the rays perform in the usual practice. | Day 3 |
| Detection of biochemical markers | The presence or absence of these markers will be notified:
| Day 3 |
| Metabolomics markers levels | The metabolomic levels of the following molecules will be calculated on urine samples:
|
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of radiation | The total dose of radiation will be calculated for each patient and compared will the biologic results. | Day 3 |
| Radiation field | The radiation field will be define for each patient and compared with the biological results. |
Not provided
Inclusion Criteria:
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Magné, PhD | Institut de Cancérologie Lucien Neuwirth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | 42270 | France | |||
| Institut Gustave Roussy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 2 |
| Day 3 |
| Villejuif |
| 94800 |
| France |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |