Validation of Radio-induced Damage Biomarkers

Bone Metastasis Clinical Trial

— BIOM-DRI  

Official title:

Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02999152
• Other study ID #: 2016-0901
• Secondary ID: 2016-A01446-45
• Status: Terminated
• Phase: N/A
• Start date: June 22, 2017
• Est. completion date: June 15, 2020

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Metastasis
• Malignant Hemopathy
• Neoplasm Metastasis

Intervention

Other:
• blood and urines samples
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.

Locations

Country	Name	City	State
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest en Jarez
France	Institut Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut de Cancérologie de la Loire, Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of haematological and biochemical markers	The following bio-markers levels will be calculated : Blood count,; Pads,; Haemoglobin,; Serum iron,; Plasma urea,; Urinary urea; Total protein,; albumin; creatin kinase,; Aspartate Amino Transferase,; alkaline phosphatase,; Total cholesterol,; Triglycerides,; Plasma creatinine; Creatinine clearance,; Urinary creatinine; Blood glucose,; Citrulline,; erythropoietin,; Plasma amylase,; Myoglobin,; Troponin,; C reactive protein,; Rate of prothrombin,; Fibrinogen,; D-Dimer,; Factor-V,; Fms-like tyrosine kinase 3-Ligand.	Day 3
Primary	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
Primary	Detection of biochemical markers	The presence or absence of these markers will be notified: Interleukin 1; Interleukin 6; Interleukin 8; Interleukin 18; Tumor Necrosis Factor alpha (TNF-alpha); Brain-Derived Neurotrophic Factor (BDNF); Granulocyte Colony-Stimulating Factor (G - CSF); Serum amyloid A (SAA); Growth Arrest and DNA Damage-inducible 45 (GADD45); Intestinal-type Fatty Acid-Binding Protein (FABP-I); Liver-type Fatty Acid-Binding Protein (L-FABP); Heart-type Fatty Acid-Binding Protein (H-FABP); Stem Cell Factor Receptor CD117	Day 3
Primary	Metabolomics markers levels	The metabolomic levels of the following molecules will be calculated on urine samples: 3 - Sulfate Hydroxytyrosol; 1, 6-Anhydro-beta-D-glucose; 1 - Methylnicotinamide; 2 - Hydroxyisobutyrate; 3 - aminoisobutyrate; 3 - hydroxyisovalerate; 3 - Hydroxymandelate; 3 - Indoxylsulfate; 4 - Hydroxyphenylacetate; Acetate; Acetone; Adipic acid; Alanine; Betaine; Carnitine; Choline; Cis-Aconitate; Citrate; Creatine; Creatinine; dimethylamine; Ethanolamine; Formats; Glucose; Glycine; Glycolate; Hippurate; Histidine; Hypoxanthine; Isethionic acid; Lactate; Methanol; Methylamine; N, N-Dimethylglycine; N - Acetylserotonin sulfate; N - Acetyltaurine; O - Acetylcarnitine; O - Phosphocholine; Pi-methylhistidine; Pyroglutamate; Succinate; Tartrate; Tau-methylhistidine; Taurine; Threonine; trans-Aconitate; Trigonelline; Trimethylamine N-oxide; Tyramine sulfate; Tyrosine; Tyrosol sulfate; Uracil; Robert acid; Valine; Xanthine	Day 2
Secondary	Total dose of radiation	The total dose of radiation will be calculated for each patient and compared will the biologic results.	Day 3
Secondary	Radiation field	The radiation field will be define for each patient and compared with the biological results.	Day 3