Clinical trial · Interventional
Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response
NCT02439008CI-TRIAL-00105525terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of patient enrollment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples collection after radiotherapy | Procedure | — | UNRESOLVED |
| Blood samples collection before radiotherapy | Procedure | — | UNRESOLVED |
| Blood samples collection during radiotherapy | Procedure | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blood samples collection
- description
- 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)
- interventionNames
- Procedure: Blood samples collection before radiotherapy
- Procedure: Blood samples collection during radiotherapy
- Procedure: Blood samples collection after radiotherapy
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Analyse of immunological parameters, decription of secreted markers and nanovesicles production
- timeFrame
- from baseline to 1 year follow up
- description
- 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 outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.