临床试验/NCT06993727

NCT06993727招募中不适用

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

Laura ICONARU3 个研究点分布在 1 个国家目标入组 500 人开始时间: 2023年11月14日最近更新: 2025年5月29日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 500
试验地点: 3
主要终点: Blood level of anti-thyroglobulin antibodies (aTg)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•Pregnancy

研究组 & 干预措施

immune checkpoint therapy

Experimental

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

干预措施: Blood sampling (Other)

结局指标

主要结局

Blood level of anti-thyroglobulin antibodies (aTg)

时间窗: 6 months after baseline

Blood level of anti-thyroglobulin antibodies (aTg)

Blood level of anti-thyroperoxidase antibodies (aTPO)

时间窗: 6 months after baseline

Blood level of anti-thyroperoxidase antibodies (aTPO)

Blood levels of TSH receptor antibodies (TRAb)

时间窗: 6 months after baseline

Blood levels of TSH receptor antibodies (TRAb)

Blood level of pituitary antibody

时间窗: 6 months after baseline

Blood level of pituitary antibody

Blood level of adrenal antibody

时间窗: 6 months after baseline

Blood level of adrenal antibody

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

时间窗: 6 months after baseline

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

Blood level of anti-thyroglobulin antibodies (aTg)

时间窗: Baseline (before the start of the immunotherapy)

Blood level of anti-thyroglobulin antibodies (aTg)

时间窗: 3 months after baseline

Blood level of anti-thyroglobulin antibodies (aTg)

Blood level of anti-thyroperoxidase antibodies (aTPO)