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Study of Trans-tissular Migration of Macrophages Associated to Human Breast Cancer (Macrophages)

2016年9月12日 更新者:Institut Claudius Regaud

Surgical samples of human primitive breast: Representative and various surgical samples of human primitive breast carcinoma in terms of histological type. Moreover, healthy tissue from the same patient will be analysed in parallel. Adjacent normal epithelial structures will be defined as at least 5 mm away from the tumor and histologically normal in appearance.

Isolation, differentiation of human monocyte-derived Macrophages (Mphs) and determination of the Macrophage (Mph) migration mode : Human Mphs will be differentiated from blood monocytes isolated from the same patient than the tumor sample. Blood samples will be obtained following standard ethical procedures.

研究概览

地位

未知

条件

详细说明

Surgical samples of human primitive breast: In order to use human samples from the anatomo-pathological laboratory collection, several statements will be signed and coordinated by the legal department of Centre National de Recherche Scientifique (CNRS) and Institut National de la Santé et de la Recherche Médicale (INSERM) in accordance with Centre Hospitalier Universitaire (CHU). Representative and various surgical samples of human primitive breast carcinoma in terms of histological type (no special type, lobular etc …), grade, tumor size (except tumor less than 1 cm for having enough material), hormone receptor status, HER2 status and index of proliferation will be prospectively analysed. Moreover, healthy tissue from the same patient will be analysed in parallel. Adjacent normal epithelial structures will be defined as at least 5 mm away from the tumor and histologically normal in appearance, as independently determined by a clinical pathologist.

All clinical characteristics of the patients will be collected : age at diagnosis, body mass index, nulliparous status or not, pre-peri- or post- menopausal status, systemic adjuvant treatment in terms of hemotherapy, tailored therapy and local treatments. Moreover all histo-pathological characteristics of the infiltrative primary breast carcinoma will be determined by team 2 :histological type (no special type, lobular etc …), grade Scarff-Bloom et Richardson (SBR), tumor size, hormone receptor status (estrogen and progesterone receptor), HER2 status (overexpression/amplication), index of proliferation (count of mitosis and antigen KI67), presence or not of embole vascular, presence or not of in-situ carcinoma and nodal status. For the human breast tissue cohort, the amounts of connective tissue and collagen will be determined as percent of positive intralobular stain to total lobular area per case. Intralobular connective tissue content will be examined using Hematoxylin and Eosin (H&E) stain and fibrillar collagen content via Masson's trichrome stain.

Isolation and differentiation of human monocyte-derived Mphs: Human Mphs will be differentiated from blood monocytes isolated from the same patient than the tumor sample. Blood samples will be obtained following standard ethical procedures and with the approval of the concerned Internal Review Boards.

Human blood-derived Mphs will be stained with CellTracker™ Green 5-chloromethylfluorescein diacetate (CMFDA) Dye prior to co-culture with breast tumors explants to allow distinguishing them from endogenous Mphs in immunohistochemistry staining.

Ex vivo tumor slice preparation and co-culture with Mphs: Ex vivo tumor slices will be performed. Surgical samples will be embedded in 3% low gelling temperature agarose prepared in Phosphate Buffered Saline (PBS) to allow for easier slicing. 500-µm slices will be obtained with a microtome dedicated to live tissues, a Krumdieck tissue slicer filled with ice-cold PBS set to medium blade and arm speeds. Slices will be cultured on 30-mm cell culture insert featuring a hydrophilic PolyTetraFluoroEthene (PTFE) membrane with pore size of 0.4 µm (Merck Millipore) placed inside 6-well plates containing 1.1 mL of Dulbecco's Modified Eagle Medium (DMEM) with or without Ameboid Migration (AM) or Mensenchymal Migration (MM) inhibitors. The same day, co-cultures will be performed by seeding 5 × 105 human Monocyte Derived Macrophages (hMDMs) on top of tumor slices and left in a 37°C 5% CO2 environment. Culture medium will be replaced daily for three days before overnight fixation with formalin at 4°C (Sigma-Aldrich).

For determination of the Mph migration mode, two parameters will be evaluated to determine the migration mode of Mphs inside tumors: the sensitivity to inhibitors and the cell morphology.Mph will be layered on tumor slices from breast tumor biopsies in the presence or absence of the AM inhibitor (20 µM Y27632) or the MM inhibitor (10 µM Batimastat) to identify the Mph migration mode.

Inhibitors: If the infiltration of Mphs into tissues is inhibited by Y27632 (a ROCK inhibitor) and insensitive to protease inhibitors, and then allow to conclude that they use the AM. If the opposite is true, it will conclude that they use the MM. If inhibitors have an additional effect, it will conclude that both AM and MM are used.

Cell morphology: [Mph have an elongated and protrusive morphology during MM. In contrast, during AM, Mph show a round morphology. Although difficult to assess on ImmunoHistoChemistry (IHC) slices, Mph morphology will be analyzed. If elongated Mph can be detected, it will provide us with additional information to conclude on the migration mode.

Immunohistochemistry on tumor slices: Tumor slices used in co-cultures with hMDMs will be embedded in paraffin. For Mph infiltration quantification assays, slices will then be cut along the diameter and serial sectioning will be performed along the cut. Sections will be stained using an anti-CellTracker™ Green CMFDA Dye Rabbit Polyclonal Antibody (Life technologies) to specifically stain exogeneously added human MDMs. To determine viability of tissue slices, sections will be stained with hematoxylin and eosin to assess cell apoptosis and necrosis. Slides will then be scanned using a Panoramic 250 Flash II slide scanner (3DHISTECH, Hungary) with a 20× magnification lens..The number of Mphs per mm2 of tissues will be quantified (Mirax Scan Zeiss virtual slide scanner). This task will be accomplished withDrTalal Al Saati, supervisor of the experimental histopathology technical platform (INSERM-IFR150/Génopole Toulouse-Midi Pyrénées, CHU Purpan, Toulouse).

Value-creation of experimental results: The Mph migration mode will be identified in a significant number of human primitive breast carcinoma of each type as defined by clinicians, based on their histological type, grade, tumor size, hormone receptor status, HER2 status and index of proliferation and clinical characteristics of the patients collected by team2. Moreover, the migration mode of Mph in the healthy tissue from the same patients will be analysed in parallel and will be used as a reference of Mph migration in non-tumoral tissue in each patients. Then, it will determine i) if Mph perform MM in all types of tumor or if they use MM in some tumors and AM in others, and ii) whether a correlation exists between the migration mode used by macrophages to infiltrate tumors and the type of tumor. Finally, it will establish if there is a correlation between the invasive properties of the studied breast cancer (which will be determined by histo-pathological analysis performed by team2) and the migration mode used by Mph in order to determine whether a correlation exists between the migration mode used by macrophages and tumor invasiveness. Actually, the result expected is that when TAMs use the MM which involves proteases and deep remodeling of the extracellular matrices, the tumor invasiveness will be higher than in tumors in which Tyro-3, Axl, and Mer (TAMs) use the AM.

In the long term, the patient outcome will also be taken into account in these analyses as an additional knowledge about the relationship between TAM migration and tumor progression.

研究类型

介入性

注册 (预期的)

200

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

Inclusion Criteria:

  1. Female patient with breast cancer
  2. Age > 18 years old
  3. Available primary breast tumor sample with adjacent normal epithelial structures
  4. Informed consent obtained and signed

Exclusion Criteria:

  1. Primary tumor size < 1cm
  2. Surgical tumor sample without available adjacent normal epithelial structures

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

  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:研究组
Archival tumor samples analysis and blood sample testing

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
Analysis of Breast Tumor sample
大体时间:up to 2 years
analysis of the sensitivity to inhibitors
up to 2 years
Analysis of Breast Tumor sample
大体时间:up to 2 years
analysis of the cell morphology
up to 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。

调查人员

  • 首席研究员:Florence Dalenc, Dr、Institut Claudius Regaud

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

2016年12月1日

初级完成 (预期的)

2018年12月1日

研究完成 (预期的)

2018年12月1日

研究注册日期

首次提交

2016年7月28日

首先提交符合 QC 标准的

2016年8月18日

首次发布 (估计)

2016年8月23日

研究记录更新

最后更新发布 (估计)

2016年9月13日

上次提交的符合 QC 标准的更新

2016年9月12日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 16 SEIN 03

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Specific data base

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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