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Myeloid Cell Reprogramming in Thyroid Carcinoma

2022年1月25日 更新者:Radboud University Medical Center

Myeloid Cell Reprogramming in the Context of Radioiodine Therapy in Patients With Non-Medullary Thyroid Carcinoma

This study investigates the reprogramming of myeloid cells in patients with thyroid carcinoma. The investigators hypothesize that tumor-derived factors change the function of myeloid cells (peripheral blood and bone marrow-derived) in such a way that these immune cells promote tumor growth rather than combat the tumor.

研究概览

地位

完全的

条件

详细说明

Description of the problem:

Non-medullary thyroid carcinoma (TC) is the most common endocrine malignancy and its incidence is one of the most rapidly increasing among the cancer types. For many patients with advanced and poorly differentiated tumors, treatment options are limited and the prognosis of advanced stage metastatic disease remains poor.

Envisioned solution/research direction:

To improve the patients outcome and identify novel therapeutic targets, one needs a 'systems understanding' of the pathophysiology of tumors, particularly the complex interaction of the malignant cells with other cell types in the tumor en the tumor environment (TME), especially immune cells. Tumor-associated macrophages (TAMs), the most dominant myeloid population in aggressive thyroid tumors, exhibit a distorted phenotype functioning predominantly as tumor enhancer. Despite the progress in understanding the importance of TAMs, the in-depth characterization of different TAMs populations is lacking and the mechanisms governing the functional polarization of TAMs are largely unknown. Understanding the interplay between TAMs and tumor cells represents a crucial step towards development of additional therapeutic strategies in cancer.

Hypothesis:

  1. We first propose that in advanced TC, not only TAMs, but also circulating monocytes and bone marrow (BM) myeloid progenitors are functionally reprogrammed by tumor-derived factors even before their recruitment in the TME.
  2. Radioactive iodide (I131)(RAI) is a very effective therapy for patients with TC, but is less effective in patients with advanced, metastatic tumors. We hypothesize that by exposing tumor antigens to the immune system, RAI might induce immunogenic effects at the level of the TME with reprogramming of both TAMs present in the TME and circulating monocytes, towards a tumor suppressive phenotype. This may further potentiate the effects of RAI. In addition this could be explored in the future as a basis for immunotherapy for tumors that are refractory to conventional treatment.

研究类型

观察性的

注册 (实际的)

41

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nijmegen、荷兰、6525GA
        • Radboudumc

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Primary care clinic

描述

Inclusion Criteria:

  • Group 1:

Subject is newly diagnosed with TC, therapy-naive and is planned to receive conventional treatment by surgery followed by RAI; no evidence of local or distant metastases

  • Group 2:

Subject has TC with evidence of distant metastases (either newly diagnosed or therapy-naive or patients with persistent or recurrent disease); at least 4 months since the previous treatment with RAI if applicable

  • Group 3:

Subject is diagnosed with MNG, is euthyroid, and is planned to undergo surgery - Group 4: Subject is diagnosed with MNG, is euthyroid, and is planned to receive RAI treatment

- Group 5: Healthy individuals who are euthyroid and have no evidence of thyroid disease

Exclusion Criteria:

  • Mentally incompetent
  • Pregnant, trying to become pregnant or breastfeeding
  • Known inflammatory or infectious diseases or an immunosuppressive status
  • Using medication interfering with the immune system
  • Reduced platelet counts or other conditions associated with an increased risk of bleeding
  • Severe comorbidities: other active malignancy (except for basal cell carcinoma)
  • Serious psychiatric pathology
  • A self-reported alcohol consumption of >21 units per week

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Non-metastatic TC
blood withdrawal, bone marrow aspiration
Metastatic TC
blood withdrawal, bone marrow aspiration
MNG surgery
blood withdrawal, bone marrow aspiration
MNG RAI treatment
blood withdrawal
Healthy volunteers
blood withdrawal

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Transcriptional reprogramming of myeloid cells
大体时间:baseline
RNAseq
baseline
Epigenetic reprogramming of myeloid cells
大体时间:baseline
ATAC-seq
baseline
Functional reprogramming of myeloid cells
大体时间:baseline
Cytokine response
baseline

次要结果测量

结果测量
措施说明
大体时间
Metabolites
大体时间:baseline
Presence and level metabolites
baseline
Change of reprogramming after RAI treatment
大体时间:baseline and 7 days after RAI treatment
RNAseq
baseline and 7 days after RAI treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Romana T Netea-Maier、Endocrinologist

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年3月6日

初级完成 (实际的)

2019年11月26日

研究完成 (实际的)

2021年1月5日

研究注册日期

首次提交

2017年12月18日

首先提交符合 QC 标准的

2018年1月5日

首次发布 (实际的)

2018年1月11日

研究记录更新

最后更新发布 (实际的)

2022年2月9日

上次提交的符合 QC 标准的更新

2022年1月25日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • NL62671.091.17
  • 2017-3628 (其他标识符:CMO Arnhem-Nijmegen)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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