Exploring blood biomarkers to predict immune-related side effects in cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the role of blood biomarkers in predicting the development of immune-related adverse events (irAEs) in cancer patients undergoing treatment with immune checkpoint inhibitors (ICIs), either alone or in combination with other therapies. Participants will have their blood samples and clinical data collected during routine follow-up visits, which will be analyzed to characterize immune cell populations using advanced techniques like mass and flow cytometry. The study seeks to identify specific immune mechanisms that contribute to irAEs, which can vary significantly among patients and tumor types.

Why it matters

Who can join: the full rules

* 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

Where it's running

• Brest University Hospital
  Brest, France Recruiting

Study contacts

• Principal investigator: Benjamin Auberger — CHU Brest
• Study coordinator: Benjamin Auberger
• Email: benjamin.auberger@chu-brest.fr
• Phone: +33298223740

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.