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Blood test may predict dangerous immunotherapy reactions

NCT ID NCT07249060

Knowledge-focused Sponsor: Hospital Universitario Araba 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study aims to find a way to predict which cancer patients will experience side effects from immunotherapy. These side effects happen when the immune system attacks healthy tissues, similar to autoimmune diseases. Researchers will collect blood samples from 300 cancer patients starting immunotherapy and 40 people with autoimmune diseases to measure substances called interferons. The goal is to develop a test that helps doctors identify high-risk patients before treatment begins.

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 300 people

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

Started

Jan 2024

Expected to finish

Dec 2026

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

ICI cohort: Patients in the ICI cohort will be recruited from the Medical Oncology outpatient clinics of the participating hospitals. All patients diagnosed with a solid neoplasm eligible for treatment with ICIs will be considered for inclusion, using consecutive case sampling. SAD cohort: Patients in the SAD cohort will be recruited in the outpatient clinics of the HUN Internal Medicine Service's SAD Unit, using consecutive case sampling.

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.

ICI cohort: Inclusion Criteria: * Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines; * Patients who are treatment-naïve to ICIs; and * Age ≥18 years. Exclusion Criteria: * Estimated mortality of less than 3 months from the start of treatment; * Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments; * Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group \[ECOG\] ≥3); * Ongoing immunosuppressive therapy, including prednisone at doses \>10 mg/day or equivalent. SAD cohort: Inclusion Criteria: * Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR/EULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR/EULAR 2016), Systemic Sclerosis (SSc) (ACR/EULAR 2013), and/or Idiopathic Inflammatory Myopathy (IIM) (ACR/EULAR 2017). * Age ≥18 years old. Exclusion Criteria: * Estimated mortality less than 3 months from the start of follow-up. * Active immunosuppressive treatment, including prednisone at doses \>10 mg/day or equivalent. * Recent diagnosis (\<1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy idiopathic inflammatory myopathy myositis disease neoplasm Sjogren syndrome systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Immune-related adverse events Inflammatory myopathies Lupus erythematosus, systemic Sjogren syndrome Solid tumors Systemic sclerosis (SSC)

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

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

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