Carcinoma, Hepatocellular, Colorectal Neoplasms, Kidney Neoplasms, Melanoma
Conditions
Keywords
liver metastases of colorectal cancer, metastases of melanoma or renal cancer
Brief summary
This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy and a rationale for adjuvant immunotherapy.
Detailed description
* Patient information and collection of a signed informed consent form * Clinical data collection * Blood samples of 35 mL: 1. after registration, prior to the first fraction of radiotherapy 2. within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions 3. one week, 3 months, 6 months, 9 months and 12 months after the last radiotherapy session * Storage of the blood samples at ambient temperature * Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis * Destruction of the samples at the end of the analysis
Interventions
PROCEDUREBlood samples collection before radiotherapy
Nine blood samples (35 mL each) will be collected in each patient before, during and after radiotherapy treatment. Before radiotherapy: * Sample T0: after registration, in the days running up to the administration of the first fraction of radiotherapy
PROCEDUREBlood samples collection during radiotherapy
* Sample T1: within 15 minutes after the administration of the first fraction, * Sample T2: within 15 minutes after the administration of the second fraction, * Sample T3: within 15 minutes after the administration of the third fraction
PROCEDUREBlood samples collection after radiotherapy
* Sample T4: one week after the end of the radiotherapy, * Samples T5 to T8: respectively 3 months, six months, 9 months and 12 months after the end of the radiotherapy.
RADIATIONRadiotherapy
Sponsors
Centre Oscar Lambret
Institut de Biologie de Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient requiring a hypofractionated irradiation (≥ 3 fractions, dose ≥ 9 Gy per fraction) either for : * hepatocellular carcinoma or hepatic lesion of metastatic Colorectal Cancer, * metastasis from melanoma or renal cancer, * Age ≥ 18 years old, * Registered with a social security system, * Signed written informed consent.
Exclusion criteria
* Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling, * Pregnant or breastfeeding woman, * Patient under guardianship or tutorship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyse of immunological parameters, decription of secreted markers and nanovesicles production | from baseline to 1 year follow up | Description and evolution of cell fraction, quantification of immune cells, verification of the presence and evolution of activation markers and quantification of secreted exosomes ; before, during and after radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cell viability, determined by number of live/dead cells present | from baseline to 1 year follow up | Cell viability and cell proliferation |
| Progression-free rate | from baseline to 1 year follow up | progression-free rate at 12 months |
| Number of Participants with Adverse Events related to radiotherapy | from baseline to 1 year follow up | adverse effects (acute toxicity) according to CTCAE-NCI |
Countries
France
Contacts
STUDY_DIRECTORXavier Mirabel, MD
Centre Oscar Lambret
STUDY_DIRECTORNadira Delhem, MD
Institut de Biologie de Lille
Outcome results
None listed