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

ConditionAutoimmunity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaura ICONARU

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All subjects eligible for immune checkpoint therapy at the participating study sites. The cohort will consist of all subjects who consent to participate, and to use their information for future research and publication in a scientific journal.

Disqualifiers

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sampling

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: immune checkpoint therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood level of anti-thyroglobulin antibodies (aTg)

Blood level of anti-thyroglobulin antibodies (aTg)

Time frame
Baseline (before the start of the immunotherapy)
2

Blood level of anti-thyroglobulin antibodies (aTg)

Blood level of anti-thyroglobulin antibodies (aTg)

Time frame
3 months after baseline
3

Blood level of anti-thyroglobulin antibodies (aTg)

Blood level of anti-thyroglobulin antibodies (aTg)

Time frame
6 months after baseline
4

Blood level of anti-thyroperoxidase antibodies (aTPO)

Blood level of anti-thyroperoxidase antibodies (aTPO)

Time frame
Baseline (before the start of immunotherapy)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laura ICONARU

Lead sponsor

Brugmann University Hospital

Sponsor institution