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Autoimmune Endocrine Disease Related Antibodies Before the Start of Immune Checkpoint Inhibitor Therapy

NCT06993727 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-05-29

No results posted yet for this study

Summary

Promising treatments have been added to the oncologist's arsenal in recent years. Treatments that, unlike conventional chemotherapy, do not aim to destroy cancer cells directly, but rather activate the patient's own immune system to recognize and attack tumor cells again. This new treatment is called immune checkpoint therapy. This involves administering antibodies (large Y-shaped proteins that can stick to the surface of cells) that remove the brakes from the immune system.

The disadvantage of this innovative treatment is that the rejuvenated immune system can also attack cells that we want it not to recognize - our own body's cells. This is called autoimmunity. Patients who receive immune checkpoint therapy may suffer from symptoms such as skin rashes, diarrhea, hepatitis or hypothyroidism.

The purpose of this study is to find biomarkers predictive of the development of these side effects, and possibly also predict a better outcome of the cancer therapy. The investigators will also look for the presence of antibodies against the endocrine glands (glands that produce hormones, such as the thyroid, adrenal, pituitary, and pancreas) before the start of the immune therapy.

Conditions

  • Autoimmunity

Interventions

OTHER

Blood sampling

For the analysis of the autoimmune endocrine disease related antibodies (Ab) before the start of the immunotherapy, a blood sample will be collected aligned with the first visit with the treating gastro-enterologist/oncologist/pneumologist for analysis of: anti-thyroglobulin Ab (aTg), anti-thyroperoxidase Ab (aTPO), TSH receptor antibodies (TRAb), pituitary Ab, adrenal Ab, and anti-glutamic acid decarboxylase (GAD) Ab.

Sponsors & Collaborators

  • Laura ICONARU

    lead OTHER

Principal Investigators

  • Jeroen de Filette, MD · CHU Brugmann

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06993727 on ClinicalTrials.gov