Clinical trial · Observational
Understanding and Anticipating Therapeutic and ADverse Responses in Anti-cancer Immune Checkpoint Inhibition Towards a Better Therapeutic Management of Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The goal of this observational study is to explore the value of blood biomarkers for the purpose of predicting irAE development in cancer patients treated with immune checkpoint inihibitors (ICI) alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy). Data and blood samples will be collected from participants at different time points as part of routine follow-up visits. Data and blood samples will be analysed. Analysis will include the characterization of immune cells by mass and flow cytometry.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Occurrence of irAE over the duration of the patient's follow-up
- timeFrame
- 36 months
- description
- Apparition of irAE is appreciated according the physician definition. The description and grading scales of irAE found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
Secondary outcomes (3)
- measure
- Survival (PFS).
- timeFrame
- 36 months
- description
- PFS is defined as the time from random assignment in the clinical trial to disease progression or death from any cause.
- measure
- Survival (OS).
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Age ≥ 18 years old * ECOG performance status ≤ 1 * Must have histologically or cytologically confirmed tumour, eligible for treatment with ICI as standard-of-care alone or in combination with another ICI, ICI with chemotherapy, ICI with radiotherapy, or ICI with targeted therapy with no restrictions on number of prior systemic therapies * Adequate bone marrow function as defined below * Absolute neutrophil count ≥ 1500/µL or 1.5x109/L * Hemoglobin ≥ 9 g/dL * Platelets ≥ 100000/µL or 100x109/L * Adequate liver function as defined below * Serum total bilirubin ≤ 1.5 x ULN. In case of known Gilbert's syndrome \< 3xUNL is allowed * AST (SGOT)/ALT (SGPT) ≤ 3.0 x ULN * Alkaline phosphatase ≤ 3.3 x ULN * Adequate renal function as defined below \_- Creatinine ≤ 1.5 x UNL or creatinine clearance \> 60 mL/min * Patient monitored for their cancer at CHU of Brest * Did not oppose for their samples and clinical data to be used for translational research * Non-opposition form obtained prior to any study related procedure Exclusion Criteria: * Patient with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study * Patient already receiving ICI * Primary immunodeficiency and/or history of allogenic transplantation * Current active infection * Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection) * Subject of guardianship (tutorship, curatorship) * Active pregnancy
References
Publications (0)
Data not yet available