Validation of Radio-induced Damage Biomarkers (BIOM-DRI)

February 4, 2022 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Priest en Jarez, France, 42270
        • Institut de Cancérologie Lucien Neuwirth
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Level of haematological and biochemical markers
Time Frame: Day 3

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
Quantification of chromosomal aberrations
Time Frame: Day 3
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
Time Frame: Day 3

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
Metabolomics markers levels
Time Frame: Day 2

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total dose of radiation
Time Frame: Day 3
The total dose of radiation will be calculated for each patient and compared will the biologic results.
Day 3
Radiation field
Time Frame: Day 3
The radiation field will be define for each patient and compared with the biological results.
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut de Cancérologie de la Loire
Institut de Recherche Biomedicale des Armees

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-0901
  • 2016-A01446-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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