NCT02439008

Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Carcinoma, Hepatocellular
• Colorectal Neoplasms
• Melanoma
• Kidney Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Blood 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
PROCEDURE	Blood 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
PROCEDURE	Blood 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.
RADIATION	Radiotherapy

Timeline

• Start date: 2015-09-16
• Primary completion: 2018-06-21
• Completion: 2019-03-18
• First posted: 2015-05-08
• Last updated: 2026-03-13

Locations

1 site across 1 country: France