Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02439008
Recruitment Status : Terminated (Lack of patient enrollment)
First Posted : May 8, 2015
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Institut de Biologie de Lille
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Colorectal Neoplasms Melanoma Kidney Neoplasms Procedure: Blood samples collection before radiotherapy Procedure: Blood samples collection during radiotherapy Procedure: Blood samples collection after radiotherapy Radiation: Radiotherapy Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response
Actual Study Start Date : September 16, 2015
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : March 18, 2019


Arm Intervention/treatment
Experimental: Blood samples collection

Nine blood samples will be collected in each patient before, during and after radiotherapy treatment.

Interventions :

  • Blood samples collection before radiotherapy (T0)
  • Blood samples collection during radiotherapy (T1-T3)
  • Blood samples collection after radiotherapy (T4-T8)
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



Primary Outcome Measures :
  1. Analyse of immunological parameters, decription of secreted markers and nanovesicles production [ Time Frame: 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 Outcome Measures :
  1. Cell viability, determined by number of live/dead cells present [ Time Frame: from baseline to 1 year follow up ]
    Cell viability and cell proliferation

  2. Progression-free rate [ Time Frame: from baseline to 1 year follow up ]
    progression-free rate at 12 months

  3. Number of Participants with Adverse Events related to radiotherapy [ Time Frame: from baseline to 1 year follow up ]
    adverse effects (acute toxicity) according to CTCAE-NCI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439008


Locations
Layout table for location information
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Institut de Biologie de Lille
Investigators
Layout table for investigator information
Study Director: Xavier Mirabel, MD Centre Oscar Lambret
Study Director: Nadira Delhem, MD Institut de Biologie de Lille

Layout table for additonal information
Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02439008     History of Changes
Other Study ID Numbers: EarlyBio-HypoRT-WP3-1504
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Keywords provided by Centre Oscar Lambret:
liver metastases of colorectal cancer
metastases of melanoma or renal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Colorectal Neoplasms
Carcinoma, Hepatocellular
Kidney Neoplasms
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Liver Neoplasms
Liver Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases