Bone MetastasisBIOM-DRINCT02999152
Validation of Radio-induced Damage Biomarkers
A study testing blood and urines samples in people with Bone Metastasis and Malignant Hemopathy, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bone Metastasis, Malignant Hemopathy
- What is being tested?
- blood and urines samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Jun 2017to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Metastasis, Malignant Hemopathy
- Being tested
- blood and urines samples
- Keywords
- Bio-markers, Radiation, Appropriate therapeutic strategy, Total Body Irradiation, Partial Body Irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and urines samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: blood and urines samples |
| 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. Receives: Other: blood and urines samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 3
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
Measured: Day 3
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
Measured: Day 2
Secondary outcomes (2)
Total dose of radiation
The total dose of radiation will be calculated for each patient and compared will the biologic results.
Measured: Day 3
Radiation field
The radiation field will be define for each patient and compared with the biological results.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start22 Jun 2017
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Why it stopped: Low rythm of inclusions, financial support terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche Biomedicale des Armees, Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Nicolas Magné, PhD, Principal investigator, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999152
- Sponsor's protocol ID
- 2016-0901
- Other IDs
- 2016-A01446-45
- Acronym
- BIOM-DRI
- Status last verified
- Feb 2022
- First submitted
- 21 Sep 2016
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study
- ClinicalTrials.gov ID
- NCT02999152
- Acronym / sponsor ID
- BIOM-DRI / 2016-0901
- Conditions
- Bone Metastasis, Malignant Hemopathy
- Keywords
- Bio-markers, Radiation, Appropriate therapeutic strategy, Total Body Irradiation, Partial Body Irradiation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rythm of inclusions, financial support terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Recherche Biomedicale des Armees, Institut de Cancérologie de la Loire
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Body Irradiation | Experimental | Other: blood and urines samplesPatient 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 | Other: blood and urines samplesPatient 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and urines samplesFor 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. | Other | Partial Body Irradiation, Total Body Irradiation |
Primary outcome
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.
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.
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
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
2 secondary outcomes
Total dose of radiation
Time frame: Day 3
Radiation field
Time frame: Day 3
Results and safety
The study was stopped early (reason given: Low rythm of inclusions, financial support terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Magné, PhD principal investigator
Institut de Cancérologie Lucien Neuwirth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood and urines samples in people with Bone Metastasis and Malignant Hemopathy, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low rythm of inclusions, financial support terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of haematological and biochemical markers (time frame: Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.