RecruitingNot ApplicableNCT06993727

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

Prospective Study of Autoimmune Endocrine Disease-related Antibodies Before the Start of Immune Checkpoint Inhibitor Therapy


Sponsor

Laura ICONARU

Enrollment

500 participants

Start Date

Nov 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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.

Exclusion Criteria1

  • Pregnancy

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Interventions

OTHERBlood 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.


Locations(3)

C.H.U. Saint-Pierre

Brussels, Belgium

CHU Brugmann

Brussels, Belgium

HUB - Institut Jules Bordet

Brussels, Belgium

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NCT06993727


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