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

NCT ID: NCT02439008

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-16
• Study Completion Date: 2019-03-18

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

Conditions

Carcinoma, Hepatocellular; Colorectal Neoplasms; Melanoma; Kidney Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Blood samples collection before radiotherapy

Intervention Type: PROCEDURE

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

Blood samples collection during radiotherapy

Intervention Type: PROCEDURE

• 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

Blood samples collection after radiotherapy

Intervention Type: PROCEDURE

• 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.

Radiotherapy

Intervention Type: RADIATION

Interventions

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: PROCEDURE

Radiotherapy

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Biologie de Lille

OTHER

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Mirabel, MD

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Nadira Delhem, MD

Role: STUDY_DIRECTOR

Institut de Biologie de Lille

Locations

Centre Oscar Lambret

Lille, , France

Countries

France

Other Identifiers

EarlyBio-HypoRT-WP3-1504

Identifier Type: -

Identifier Source: org_study_id