Validation of Radio-induced Damage Biomarkers (BIOM-DRI)
Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Saint-Priest en Jarez, Frankrijk, 42270
- Institut de Cancérologie Lucien Neuwirth
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Villejuif, Frankrijk, 94800
- Institut Gustave Roussy
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Total Body Irradiation
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.
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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. |
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Experimenteel: Partial Body Irradiation
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.
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Level of haematological and biochemical markers
Tijdsspanne: Day 3
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The following bio-markers levels will be calculated :
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Day 3
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Quantification of chromosomal aberrations
Tijdsspanne: Day 3
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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.
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Day 3
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Detection of biochemical markers
Tijdsspanne: Day 3
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The presence or absence of these markers will be notified:
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Day 3
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Metabolomics markers levels
Tijdsspanne: Day 2
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The metabolomic levels of the following molecules will be calculated on urine samples:
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Day 2
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Total dose of radiation
Tijdsspanne: Day 3
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The total dose of radiation will be calculated for each patient and compared will the biologic results.
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Day 3
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Radiation field
Tijdsspanne: Day 3
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The radiation field will be define for each patient and compared with the biological results.
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Day 3
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2016-0901
- 2016-A01446-45 (Andere identificatie: ANSM)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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