Actively Recruiting
Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
Led by Neolys · Updated on 2024-11-22
100
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
N
Neolys
Lead Sponsor
C
Centre Francois Baclesse
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to analyze individual radiosensitivity in children and adolescents with cancer, focusing on how their bodies respond to radiation therapy. It targets pediatric patients treated for brain tumors, Ewing tumors, malignant mesenchymal tumors, neuroblastoma, nephroblastoma, or Hodgkin's lymphoma who are undergoing radiotherapy, sometimes alongside chemotherapy, for curative purposes. The study is sponsored by Neolys and investigates a blood test called RadioDtect to predict radiation-related toxicities. Participants will provide blood samples to perform the RadioDtect test, which involves collecting two 5 ml blood samples. The study evaluates the test's ability to identify early and late radiation-induced toxicities over periods of 12 and 24 months. The radiation treatments follow standard fractionation schedules, typically 1.8 Gy to 2.2 Gy per fraction, five fractions per week. During the study, participants will undergo blood sample collection and be monitored for any side effects related to radiation therapy. Researchers will assess early and late radiation-induced toxicities to validate the test's predictive capacity. The study includes follow-up assessments up to 24 months to track outcomes, with participation lasting through these evaluation periods.
CONDITIONS
Brief Title
Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minor patient treated for a brain tumor, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, Hodgkin's lymphoma treated with radiotherapy (+/- chemotherapy) for curative purposes
- Children or adolescents > 3 years old and < 18 years old
- Patient with an indication for radiotherapy as part of the primary tumor local control strategy
- Theoretical indication for radiotherapy in standard fractionation (1.8 Gy to 2.2 Gy / fraction: 5 fr/week) whatever the technique and the particle used
- Patient affiliated with a social security scheme
- Patient and/or parents or holders of parental authority having dated and signed an informed consent
You will not qualify if you...
- Patients with contraindications to blood sampling
- Patients with contraindications to radiotherapy
- Palliative radiotherapy
- Patient with previous RT treatment in the same area (re-irradiation)
- Patient with an indication of hypofractionated RT
- Patient follow-up not possible
- Persons deprived of liberty or under guardianship (including curatorship)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants provide blood samples to perform the RadioDtect test for individual radiosensitivity analysis while their response to radiotherapy is monitored over time.
1 blood sample collection visit
Trial Site Locations
Total: 2 locations
1
Centre François Baclesse
Caen, France
Actively Recruiting
2
Centre Oscar Lambret
Lille, France
Not Yet Recruiting
Research Team
S
Sandrine PEREIRA, PhD
J
Jennifer RUOS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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