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

NCT06993727 | Recruiting

• 1 other identifier: CHUB-AC after ICI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (18)

• Blood level of anti-thyroglobulin antibodies (aTg)

  Blood level of anti-thyroglobulin antibodies (aTg)

  Baseline (before the start of the immunotherapy)

• Blood level of anti-thyroglobulin antibodies (aTg)

  Blood level of anti-thyroglobulin antibodies (aTg)

  3 months after baseline

• Blood level of anti-thyroglobulin antibodies (aTg)

  Blood level of anti-thyroglobulin antibodies (aTg)

  6 months after baseline

• Blood level of anti-thyroperoxidase antibodies (aTPO)

  Blood level of anti-thyroperoxidase antibodies (aTPO)

  Baseline (before the start of immunotherapy)

• Blood level of anti-thyroperoxidase antibodies (aTPO)

  Blood level of anti-thyroperoxidase antibodies (aTPO)

  3 months after baseline

• Blood level of anti-thyroperoxidase antibodies (aTPO)

  Blood level of anti-thyroperoxidase antibodies (aTPO)

  6 months after baseline

• Blood levels of TSH receptor antibodies (TRAb)

  Blood levels of TSH receptor antibodies (TRAb)

  Baseline (before the start of immunotherapy)

• Blood levels of TSH receptor antibodies (TRAb)

  Blood levels of TSH receptor antibodies (TRAb)

  3 months after baseline

• Blood levels of TSH receptor antibodies (TRAb)

  Blood levels of TSH receptor antibodies (TRAb)

  6 months after baseline

• Blood level of pituitary antibody

  Blood level of pituitary antibody

  Baseline (before the start of immunotherapy)

• Blood level of pituitary antibody

  Blood level of pituitary antibody

  3 months after baseline

• Blood level of pituitary antibody

  Blood level of pituitary antibody

  6 months after baseline

• Blood level of adrenal antibody

  Blood level of adrenal antibody

  Baseline (before the start of immunotherapy)

• Blood level of adrenal antibody

  Blood level of adrenal antibody

  3 months after baseline

• Blood level of adrenal antibody

  Blood level of adrenal antibody

  6 months after baseline

• Blood level of anti-glutamic acid decarboxylase (GAD) antibody

  Blood level of anti-glutamic acid decarboxylase (GAD) antibody

  Baseline (before the start of immunotherapy)

• Blood level of anti-glutamic acid decarboxylase (GAD) antibody

  Blood level of anti-glutamic acid decarboxylase (GAD) antibody

  3 months after baseline

• Blood level of anti-glutamic acid decarboxylase (GAD) antibody

  Blood level of anti-glutamic acid decarboxylase (GAD) antibody

  6 months after baseline

Study Arms (1)

immune checkpoint therapy

EXPERIMENTAL

The study aims to include all subjects eligible for immune checkpoint therapy at the participating study sites.

Other: Blood sampling

Interventions

Blood sampling OTHER

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.

immune checkpoint therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Laura ICONARU: lead

Study Sites (3)

C.H.U. Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

HUB - Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jeroen de Filette, MD

  CHU Brugmann

  STUDY DIRECTOR

Central Study Contacts

Jeroen de Filette, MD

CONTACT

024772067; Jeroen.DEFILETTE@chu-brugmann.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of endocrinology clinic

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: November 14, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)