Validation of Radio-induced Damage Biomarkers (BIOM-DRI)
Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Saint-Priest en Jarez, Frankreich, 42270
- Institut de Cancérologie Lucien Neuwirth
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Villejuif, Frankreich, 94800
- Institut Gustave Roussy
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Level of haematological and biochemical markers
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Total dose of radiation
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2016-0901
- 2016-A01446-45 (Andere Kennung: ANSM)
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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Klinische Studien zur blood and urines samples
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Carlos Simon FoundationRekrutierung
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