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细胞治疗用于乳腺癌:注册临床试验(分期未知)(Centre Jean Perrin)

英文原题:Correlation Between TILs and Blood Cell Counts in Triple Negative Breast Cancer Patients

ClinicalTrials.gov 2019/08/28(首次登记) 注册临床试验(分期未标注) · 进行中(不再招募)

简要介绍

这是一项分期未标注的注册临床试验,评估细胞治疗用于乳腺癌的安全性、可行性及初步疗效。当前状态:进行中(不再招募)。计划入组 90 例。试验地点:欧洲 · 克莱蒙费朗(共 1 个中心)。登记号:NCT04068623。

入组条件决定能不能参加

仅女性 · ≥ 18 Years · 接受健康志愿者

纳入标准:

• 女性。
• 年龄>18岁。
• 确诊原发性、非转移性、组织学证实的三阴性乳腺癌。
• 接受过化疗、手术和放疗。
• 能够理解法语。
• 已参加社会保障体系。
• 已获得签署的书面知情同意。

排除标准:

• 男性。
• 入组前无可用肿瘤样本。
• 无入组前基线血液检测结果。
核对登记原文(英文)
Inclusion Criteria:

* Female
* Age \> 18 years
* Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
* Patient treated with chemotherapy, surgery and radiation therapy
* Patient able to understand the French language
* Patient affiliated to social security
* Obtaining signed written consent

Exclusion Criteria:

* Male
* Unavailable tumoral samples before inclusion
* Unavailable blood test results at baseline, before inclusion

以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。

研究终点衡量什么算有效

  • 主要终点评估诊断时三阴性乳腺癌女性活检组织淋巴细胞浸润率与血样NLR的相关性3年(招募期)
  • 次要终点评估诊断时活检TIL与血细胞计数各项指标(白细胞、中性粒细胞、淋巴细胞、血小板及PLR)的相关性
  • 次要终点评估诊断时血细胞计数指标(白细胞、中性粒细胞、淋巴细胞、血小板、NLR和PLR)与新辅助化疗组织学应答的相关性
  • 次要终点评估诊断时血细胞计数指标(白细胞、中性粒细胞、淋巴细胞、血小板、NLR和PLR)与新辅助化疗后手术标本TIL的相关性
  • 次要终点评估术前血细胞计数指标(白细胞、中性粒细胞、淋巴细胞、血小板、NLR和PLR)与新辅助化疗后手术时淋巴细胞浸润率的相关性
  • 次要终点ctDNA与转移性复发的关系
  • 次要终点白细胞水平与循环肿瘤DNA(ctDNA)存在情况的关系
  • 次要终点淋巴细胞水平与循环肿瘤DNA(ctDNA)存在情况的关系
  • 次要终点中性粒细胞水平与循环肿瘤DNA(ctDNA)存在情况的关系
核对登记原文(英文)

主要终点:Assessment of the correlation between the lymphocyte infiltration rate assessed on biopsy, and the NLR (neutrophil-to-lymphocyte ratio) measured on blood samples, in women with triple negative breast cancer, at the time of diagnosis. · * The value of NLR at diagnosis; * Tumor lymphocyte infiltration rate before treatment. · 3 years (the period of recruitment)
次要终点:Assessment of the correlation between the TILs assessed on biopsy, and the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets and PLR (Platelet-to-Lymphocyte Ratio)), at the time of diagnosis.;Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) at the time of diagnosis, and the histological response to neo-adjuvant chemotherapy;Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) at the time of diagnosis, and the TILs at surgery specimen after neoadjuvant chemotherapy.;Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) before surgery, and the lymphocyte infiltration rate at surgery after neoadjuvant chemotherapy.;Relationship between ctDNA and the metastatic relapse;Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA);Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA);Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA)

研究设计怎么做的

研究类型
观察性研究
入组人数
90 人(预计)
  • 三阴性乳腺癌患者
核对分组登记原文(英文)
  • Triple negative breast cancer

关键日期

开始日期
2019-12-04
主要完成日期
2027-10
全部完成日期
2032-10
登记状态核实于
2026-03

联系与责任方

申办方
Centre Jean Perrin

登记简述

PERCEPTION研究旨在评估三阴性乳腺癌患者在基线和手术后血细胞计数(白细胞、中性粒细胞、淋巴细胞、血小板、中性粒细胞/淋巴细胞比值〔NLR〕及血小板/淋巴细胞比值〔PLR〕)与肿瘤浸润淋巴细胞(TIL)之间的相关性。研究还将评估这些循环指标及循环肿瘤DNA作为三阴性乳腺癌转移性复发预测因子的价值。

核对登记原文(英文)

The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.

登记原文与核验信息

试验登记号
NCT04068623
试验状态
进行中(不再招募)
试验中心
Centre Jean PERRIN · 克莱蒙费朗 · 法国
适应症(原文)
Triple Negative Breast Cancer
干预方式(原文)
Blood sample