AutoimmunityNCT06993727
Autoimmune Endocrine Disease Related Antibodies Before the Start of Immune Checkpoint Inhibitor Therapy
A study testing Blood sampling in people with Autoimmunity, run by Laura ICONARU at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmunity
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesBelgium
- Study dates
- 14 Nov 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
C.H.U. Saint-Pierre
Brussels, 1000
Kris Poppe, MD, kris.poppe@stpierre-bru.be
Kris Poppe, MD
- Recruiting
CHU Brugmann
Brussels, 1020
Jeroen de Filette, MD, 3224772067, Jeroen.DEFILETTE@chu-brugmann.be
Jeroen de Filette, MD
- Recruiting
HUB - Institut Jules Bordet
Brussels, 1070
Maxime ILZKOVITZ, MD, 0032 02 541 35 91, maxime.ilzkovitz@hubruxelles.be
Maxime ILZKOVITZ, MD
About this study
Official title: Prospective Study of Autoimmune Endocrine Disease-related Antibodies Before the Start of Immune Checkpoint Inhibitor Therapy
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.
Read the detailed description
Immune checkpoint inhibitor therapy (ICI) is the current standard of care for many malignancies, due to its unique mechanism of action. These therapies release the brakes of the immune system by targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4, e.g., ipilimumab, tremelimumab), programmed cell death-1 (PD-1, e.g., cemiplimab, dostarlimab, pembrolizumab, nivolumab) or its ligand (PD-L1, e.g., atezolizumab, avelumab, durvalumab). The flip side of the coin are immune-related adverse events (IrAE), including skin, intestinal and endocrinological toxicity, although any organ system can potentially be affected.
The prospective follow-up of the endocrine autoantibodies is an area of interest as the presence of thyroid autoantibodies is associated with the occurrence of thyroiditis with immunotherapy.
In turn, the occurrence of thyroiditis with immunotherapy is related to improved oncologic prognosis. Therefore, it would be of value to analyze whether the presence of thyroid autoimmunity (with positive thyroperoxidase and/or thyroglobulin autoantibodies) before the start of immunotherapy could be a marker of improved oncologic prognosis and outcome.
Furthermore, there is a gap in our knowledge of the impact of autoantibodies against less common endocrinopathies, such as hypophysitis (inflammation of the pituitary gland), adrenalitis (inflammation of the adrenal glands) or pancreas (type-1 like diabetes mellitus). Finding a prognostic factor for these types of endocrinopathy is equally important, as these patients may present with life-threatening endocrinopathy (adrenal crisis, diabetic ketoacidosis) and should be recognized and treated in a timely manner.
The main purpose of the current study is to evaluate the association between the autoimmune endocrine disease-related antibodies, the development of endocrine irAE and the impact on the tumor response including progression-free survival and overall survival.
For this study, the investigators aim to perform a blood sample before and during the immunotherapy, for the analysis of the autoimmune endocrine disease related antibodies (Ab): anti-thyroglobulin Ab (aTg), anti-thyroperoxidase Ab (aTPO), anti-TSH-receptor Ab (TSI), pituitary Ab, adrenal Ab, and anti-GAD. The included patients will be prospectively followed up.
- Conditions
- Autoimmunity
- Being tested
- Blood sampling
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| immune checkpoint therapy | Experimental | The study aims to include all subjects eligible for immune checkpoint therapy at the participating study sites. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood level of anti-thyroglobulin antibodies (aTg)
Blood level of anti-thyroglobulin antibodies (aTg)
Measured: Baseline (before the start of the immunotherapy)
Blood level of anti-thyroglobulin antibodies (aTg)
Blood level of anti-thyroglobulin antibodies (aTg)
Measured: 3 months after baseline
Blood level of anti-thyroglobulin antibodies (aTg)
Blood level of anti-thyroglobulin antibodies (aTg)
Measured: 6 months after baseline
Blood level of anti-thyroperoxidase antibodies (aTPO)
Blood level of anti-thyroperoxidase antibodies (aTPO)
Measured: Baseline (before the start of immunotherapy)
Blood level of anti-thyroperoxidase antibodies (aTPO)
Blood level of anti-thyroperoxidase antibodies (aTPO)
Measured: 3 months after baseline
Blood level of anti-thyroperoxidase antibodies (aTPO)
Blood level of anti-thyroperoxidase antibodies (aTPO)
Measured: 6 months after baseline
Blood levels of TSH receptor antibodies (TRAb)
Blood levels of TSH receptor antibodies (TRAb)
Measured: Baseline (before the start of immunotherapy)
Blood levels of TSH receptor antibodies (TRAb)
Blood levels of TSH receptor antibodies (TRAb)
Measured: 3 months after baseline
Blood levels of TSH receptor antibodies (TRAb)
Blood levels of TSH receptor antibodies (TRAb)
Measured: 6 months after baseline
Blood level of pituitary antibody
Blood level of pituitary antibody
Measured: Baseline (before the start of immunotherapy)
Blood level of pituitary antibody
Blood level of pituitary antibody
Measured: 3 months after baseline
Blood level of pituitary antibody
Blood level of pituitary antibody
Measured: 6 months after baseline
Blood level of adrenal antibody
Blood level of adrenal antibody
Measured: Baseline (before the start of immunotherapy)
Blood level of adrenal antibody
Blood level of adrenal antibody
Measured: 3 months after baseline
Blood level of adrenal antibody
Blood level of adrenal antibody
Measured: 6 months after baseline
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Measured: Baseline (before the start of immunotherapy)
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Measured: 3 months after baseline
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start14 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutoimmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura ICONARU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura ICONARU, Brugmann University Hospital
- Investigators
- Jeroen de Filette, MD, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993727
- Sponsor's protocol ID
- CHUB-AC after ICI
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Autoimmune Endocrine Disease-related Antibodies Before the Start of Immune Checkpoint Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT06993727
- Acronym / sponsor ID
- CHUB-AC after ICI
- Conditions
- Autoimmunity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Laura ICONARUUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Immune checkpoint inhibitor therapy (ICI) is the current standard of care for many malignancies, due to its unique mechanism of action. These therapies release the brakes of the immune system by targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4, e.g., ipilimumab, tremelimumab), programmed cell death-1 (PD-1, e.g., cemiplimab, dostarlimab, pembrolizumab, nivolumab) or its ligand (PD-L1, e.g., atezolizumab, avelumab, durvalumab). The flip side of the coin are immune-related adverse events (IrAE), including skin, intestinal and endocrinological toxicity, although any organ system can potentially be affected.
The prospective follow-up of the endocrine autoantibodies is an area of interest as the presence of thyroid autoantibodies is associated with the occurrence of thyroiditis with immunotherapy.
In turn, the occurrence of thyroiditis with immunotherapy is related to improved oncologic prognosis. Therefore, it would be of value to analyze whether the presence of thyroid autoimmunity (with positive thyroperoxidase and/or thyroglobulin autoantibodies) before the start of immunotherapy could be a marker of improved oncologic prognosis and outcome.
Furthermore, there is a gap in our knowledge of the impact of autoantibodies against less common endocrinopathies, such as hypophysitis (inflammation of the pituitary gland), adrenalitis (inflammation of the adrenal glands) or pancreas (type-1 like diabetes mellitus). Finding a prognostic factor for these types of endocrinopathy is equally important, as these patients may present with life-threatening endocrinopathy (adrenal crisis, diabetic ketoacidosis) and should be recognized and treated in a timely manner.
The main purpose of the current study is to evaluate the association between the autoimmune endocrine disease-related antibodies, the development of endocrine irAE and the impact on the tumor response including progression-free survival and overall survival.
For this study, the investigators aim to perform a blood sample before and during the immunotherapy, for the analysis of the autoimmune endocrine disease related antibodies (Ab): anti-thyroglobulin Ab (aTg), anti-thyroperoxidase Ab (aTPO), anti-TSH-receptor Ab (TSI), pituitary Ab, adrenal Ab, and anti-GAD. The included patients will be prospectively followed up.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immune checkpoint therapy | Experimental | Other: Blood samplingThe study aims to include all subjects eligible for immune checkpoint therapy at the participating study sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingFor 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. | Other | immune checkpoint therapy |
Primary outcome
Blood level of anti-thyroglobulin antibodies (aTg)
Time frame: Baseline (before the start of the immunotherapy)
Blood level of anti-thyroglobulin antibodies (aTg)
Blood level of anti-thyroglobulin antibodies (aTg)
Time frame: 3 months after baseline
Blood level of anti-thyroglobulin antibodies (aTg)
Blood level of anti-thyroglobulin antibodies (aTg)
Time frame: 6 months after baseline
Blood level of anti-thyroglobulin antibodies (aTg)
Blood level of anti-thyroperoxidase antibodies (aTPO)
Time frame: Baseline (before the start of immunotherapy)
Blood level of anti-thyroperoxidase antibodies (aTPO)
Blood level of anti-thyroperoxidase antibodies (aTPO)
Time frame: 3 months after baseline
Blood level of anti-thyroperoxidase antibodies (aTPO)
Blood level of anti-thyroperoxidase antibodies (aTPO)
Time frame: 6 months after baseline
Blood level of anti-thyroperoxidase antibodies (aTPO)
Blood levels of TSH receptor antibodies (TRAb)
Time frame: Baseline (before the start of immunotherapy)
Blood levels of TSH receptor antibodies (TRAb)
Blood levels of TSH receptor antibodies (TRAb)
Time frame: 3 months after baseline
Blood levels of TSH receptor antibodies (TRAb)
Blood levels of TSH receptor antibodies (TRAb)
Time frame: 6 months after baseline
Blood levels of TSH receptor antibodies (TRAb)
Blood level of pituitary antibody
Time frame: Baseline (before the start of immunotherapy)
Blood level of pituitary antibody
Blood level of pituitary antibody
Time frame: 3 months after baseline
Blood level of pituitary antibody
Blood level of pituitary antibody
Time frame: 6 months after baseline
Blood level of pituitary antibody
Blood level of adrenal antibody
Time frame: Baseline (before the start of immunotherapy)
Blood level of adrenal antibody
Blood level of adrenal antibody
Time frame: 3 months after baseline
Blood level of adrenal antibody
Blood level of adrenal antibody
Time frame: 6 months after baseline
Blood level of adrenal antibody
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Time frame: Baseline (before the start of immunotherapy)
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Time frame: 3 months after baseline
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Time frame: 6 months after baseline
Blood level of anti-glutamic acid decarboxylase (GAD) antibody
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
Related trials for Autoimmunity
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeroen de Filette, MD study director
CHU Brugmann
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Autoimmunity, run by Laura ICONARU at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeroen de Filette, MD (024772067, Jeroen.DEFILETTE@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood level of anti-thyroglobulin antibodies (aTg) (time frame: Baseline (before the start of the immunotherapy)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.