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Blood test may predict dangerous side effects of cancer immunotherapy

NCT ID NCT05973344

Knowledge-focused Sponsor: University Hospital, Brest Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study is looking at whether certain markers in the blood can predict immune-related side effects in cancer patients receiving immunotherapy. Researchers will collect blood samples and health data from 200 participants during routine visits. The goal is to better understand and anticipate these side effects to improve patient care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors predict and manage side effects from immunotherapy, making treatment safer.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to a practical test or change in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients with tumors treated with ICI (anti-CTLA-4, anti-PD-1/PD-L1, LAG3, etc.) as standard-of-care, alone or in combination with other treatments (chemotherapy, radiotherapy and targeted therapy)

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brest University Hospital

    RECRUITING

    Brest, 29200, France

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