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临床试验/NCT05825547
NCT05825547已完成不适用

Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy: Descriptive Pilot Study.

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2022年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment

研究概览

简要总结

Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. Studies describe complex responses with elevated levels of activating NK cells, circulating and anti-tumor T cells, and pro-inflammatory and NF-KB dependent cytokines.

In breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. Indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells The University Hospital of Nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with Argon. This technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. The aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy.

The study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. A better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.

研究设计

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

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The patient must have given their free and informed consent
  • The patient must be a member or beneficiary of a health insurance plan
  • Patient with metastatic breast cancer with painful subcutaneous metastases.
  • Patient eligible for cryotherapy.
  • Therapeutic decision of antalgic and palliative treatment by cryotherapy taken in Pluridisciplinary Consultation Meeting.
  • Patient available for 15-day follow-up.

排除标准

  • The subject is in a period of exclusion determined by a previous study
  • The subject us unable to express their consent or refuses to sign the consent form
  • The patient is under safeguard of justice or state guardianship

结局指标

主要结局

Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment

时间窗: Day 0

Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers

Description of the immunological makeup of the tumor after liquid nitrogen cryotherapy treatment

时间窗: Day 15

Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers

次要结局

  • Patients' tolerance to cryotherapy treatment(Day 15)
  • Level of pain related to subcutaneous metastases before cryotherapy treatment(Day 0 immediately before cryotherapy treatment)
  • Level of pain related to subcutaneous metastases after cryotherapy treatment(Day 15)
  • Pain related to subcutaneous metastases before cryotherapy treatment(Day 0 immediately before cryotherapy treatment)
  • Pain related to subcutaneous metastases after cryotherapy treatment(Day 15)
  • Patient reported quality of before cryotherapy treatment(Day 0)
  • Patient reported quality of after cryotherapy treatment(Day 15)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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