Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis (TREM-1)
2022年6月20日 更新者：Centre Francois Baclesse, Luxembourg
Breast cancer is the most common cancer in the world.
Half of patients with such cancer are treated with radiation therapy.
Some patients will develop cutaneous or subcutaneous fibrosis, more or less bothersome.
Several studies have shown a correlation between an inflammatory reaction and a protein, called TREM-1.
But to date, no link has been proven between TREM-1 and inflammation / fibrosis in the phenomena of fibrosis induced by radiotherapy in patients with breast cancer.
Our study aims to understand the involvement of this TREM-1 protein in the development of fibrosis or radio-epidermis in patients with breast cancer.
研究概览
研究类型
介入性
注册 (预期的)
20
阶段
- 不适用
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。
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
不
有资格学习的性别
女性
描述
Group A
- Patients over 18 years old,
- Breast cancer (adenocarcinoma in situ or invasive)
- Non-metastatic disease
- Radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional) completed two to six months ago
- Absence of postoperative complications
- Early radio-induced epidermis grade ≥2 (CTCAE v4.0) persistent at inclusion
- Chest circumference <120 cm and Cup <E,
- Absence of breast reconstructive surgery,
- Signature of informed consent,
- Affiliation to a social security scheme for French patients.
Group B
- Patients over 18 years old,
- Breast cancer (adenocarcinoma in situ or invasive)
- Non-metastatic disease
- Radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional), completed two to six months ago
- Absence of postoperative complications
- Early grade 0-1 radiation-induced epidermis (CTCAE v4.0) at inclusion
- Chest circumference <120 cm and Cup <E,
- Absence of breast reconstructive surgery,
- Signature of informed consent,
- Affiliation to a social security scheme for French patients.
Groups C, D
Patients included in the SPLICIRAD study who have formulated their agreement for the use of supernumerary samples at the time of inclusion:
- 10 patients with late pathologic radio-induced fibrosis (more than 6 months after the end of radiotherapy), grade CTCAE v4.0 ≥ 3 vs.
- 10 patients without late pathological radio-induced fibrosis of grade CTCAE v4.0 ≤ 1 (follow-up after RT ≥4 years)
Group E Patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes.
Non-inclusion criteria for groups A, B, C, D:
- Systemic inflammatory disease associated with individual radiosensitivity
- Dermatological pathology in the breast
- Radiotherapy having delivered an overdose> 107% of the prescribed dose in at least 10% of the PTV
- Diabetes
- Active smoking
- Chronic systemic anti-inflammatory therapy, immunotherapy, immunosuppressants, anti-TNF
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
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Group A
Patients with early grade ≥2 radio-induced epidermis Intervention : blood sample
|
Blood sample of 7 mL whole venous blood in an EDTA citrate tube (4.5 mL) and a PAXgene Blood RNA tube (2.5 mL).
|
|
其他：Group B
Patients with early grade 0-1 radiation-induced epidermis Intervention : blood sample
|
Blood sample of 7 mL whole venous blood in an EDTA citrate tube (4.5 mL) and a PAXgene Blood RNA tube (2.5 mL).
|
|
无干预：Group C
Patients with late pathologic radio-induced fibrosis (more than 6 months after the end of radiotherapy), grade CTCAE v4.0 ≥ 3 No intervention : Blood sample already collected from another study and patients agree to use their blood sample for another research
|
|
|
无干预：Group D
Patients without late pathologic radio-induced fibrosis of grade CTCAE v4.0 ≤ 1 (follow-up after RT ≥4 years) No intervention : Blood sample already collected from another study and patients agree to use their blood sample for another research
|
|
|
无干预：Group E
Control group : patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes.
|
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 |
|---|---|---|
|
Coorelate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
大体时间：after recruitment of all samples, an average of 2 years
|
Correlate the amount of circulating TREM1 with the presence or absence of early persistent radiation-induced epidermis.
|
after recruitment of all samples, an average of 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy
大体时间：after recruitment of all samples, an average of 2 years
|
Correlate the amount of circulating TREM1 with the presence or absence of late radio-induced fibrosis / atrophy
|
after recruitment of all samples, an average of 2 years
|
|
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
大体时间：after recruitment of all samples, an average of 2 years
|
Intrinsic characteristics of the TREM1 blood assay in ELISA technique
|
after recruitment of all samples, an average of 2 years
|
|
correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha
大体时间：after recruitment of all samples, an average of 2 years
|
correlate TREM-1 expression with circulating markers of inflammation such as IL-6, CRP, and fibrosis such as TGF-beta, IL-1beta, TNF-alpha
|
after recruitment of all samples, an average of 2 years
|
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。
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)
2022年4月1日
初级完成 (预期的)
2024年12月31日
研究完成 (预期的)
2024年12月31日
研究注册日期
首次提交
2021年6月17日
首先提交符合 QC 标准的
2021年6月24日
首次发布 (实际的)
2021年7月2日
研究记录更新
最后更新发布 (实际的)
2022年6月23日
上次提交的符合 QC 标准的更新
2022年6月20日
最后验证
2022年6月1日
更多信息
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