NCT02999152

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

June 22, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

September 21, 2016

Last Update Submit

February 4, 2022

Conditions

Bone MetastasisMalignant Hemopathy

Keywords

Bio-markersRadiationAppropriate therapeutic strategyTotal Body IrradiationPartial Body Irradiation

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Total dose of radiation

    Day 3

  • Radiation field

    Day 3

Study Arms (2)

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.

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.

Other: blood and urines samples

Interventions

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.

Partial Body IrradiationTotal Body Irradiation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nicolas Magné, PhD

    Institut de Cancérologie Lucien Neuwirth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

December 21, 2016

Study Start

June 22, 2017

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)