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

March 12, 2026 updated by: Centre Oscar Lambret
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)
Radiation: Radiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to 1 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cell viability, determined by number of live/dead cells present
Time Frame: from baseline to 1 year follow up
Cell viability and cell proliferation
from baseline to 1 year follow up
Progression-free rate
Time Frame: from baseline to 1 year follow up
progression-free rate at 12 months
from baseline to 1 year follow up
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
from baseline to 1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

Institut de Biologie de Lille

Investigators

  • Study Director: Xavier Mirabel, MD, Centre Oscar Lambret
  • Study Director: Nadira Delhem, MD, Institut de Biologie de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2015

Primary Completion (Actual)

June 21, 2018

Study Completion (Actual)

March 18, 2019

Study Registration Dates

First Submitted

April 27, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimated)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EarlyBio-HypoRT-WP3-1504
  • 2015-A00246-43 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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