Ignite Creation Date:
2024-05-06 @ 4:03 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02439008
Status:
TERMINATED
Last Update Posted:
2019-05-23
First Post:
2015-04-27
Brief Title:
Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 Immune Response
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 Immune Response
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None