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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00246-43 | Other Identifier | ANSM |
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Lack of patient enrollment
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| Name | Class |
|---|---|
| Institut de Biologie de Lille | OTHER |
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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.
Patient information and collection of a signed informed consent form
Clinical data collection
Blood samples of 35 mL:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood samples collection | Experimental | Nine blood samples will be collected in each patient before, during and after radiotherapy treatment. Interventions :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples collection before radiotherapy | Procedure | Nine blood samples (35 mL each) will be collected in each patient before, during and after radiotherapy treatment. Before radiotherapy:
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| Measure | Description | Time Frame |
|---|---|---|
| Analyse of immunological parameters, decription of secreted markers and nanovesicles production | 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 | from baseline to 1 year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Cell viability, determined by number of live/dead cells present | Cell viability and cell proliferation | from baseline to 1 year follow up |
| Progression-free rate | progression-free rate at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Mirabel, MD | Centre Oscar Lambret | Study Director |
| Nadira Delhem, MD | Institut de Biologie de Lille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59020 | France |
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| Blood samples collection during radiotherapy | Procedure |
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| Blood samples collection after radiotherapy | Procedure |
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| Radiotherapy | Radiation |
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| from baseline to 1 year follow up |
| Number of Participants with Adverse Events related to radiotherapy | adverse effects (acute toxicity) according to CTCAE-NCI | from baseline to 1 year follow up |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D015179 | Colorectal Neoplasms |
| D008545 | Melanoma |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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