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临床试验/NCT05251805
NCT05251805终止不适用

Phase I Clinical Trial Evaluating the Safety and Feasibility of Bone Marrow Aspiration From Ribs During Thoracic Surgery

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo

研究概览

简要总结

This pilot trial is designed to evaluate the feasibility and safety of obtaining bone marrow from costal aspiration during surgery.

The investigators hypothese that sufficient bone marrow-derived HSPC's (which represent only 0,1% of the total bone marrow fraction) can be derived by rib bone marrow aspiration for ex vivo single-cell evaluation, optimization of a 3D BMN platform and preclinical ex/in vivo assessment in patient-derived organoids and murine xenograft models.

详细描述

This pilot trial is designed to evaluate the feasibility and safety of obtaining bone marrow from costal aspiration during surgery.

Previous trials demonstrated the feasibility of micro-metastasis detection in rib marrow aspirate. This procedure appears safe since no adverse events were documented during previous trials. The investigators hypothesize this technique can be used to obtain sufficient bone marrow-derived HSPC's (which represent only 0,1% of the total bone marrow fraction) for ex vivo single-cell evaluation, optimization of a 3D BMN platform and preclinical ex/in vivo assessment in patient-derived organoids and murine xenograft models. The use of rib marrow eliminates the need for extra incisions because the cuts made for trocar placement or the thoracotomy can be re-used. Therefore, the investigators hypothesize that the patients undergoing costal bone marrow aspiration during surgery will not experience extra discomfort. Every patient undergoing thoracic surgery is treated according to ERAS protocols with a major emphasis on pain control.

If the feasibility and safety of bone marrow aspiration are confirmed by this pilot trial, the investigators plan to conduct a large-scale study in which they will collect and bank blood, bone marrow and tumor per NSCLC patient. With this unique autologous biological material collection, the investigators aspire to conduct innovative research into the current resistance mechanisms of NSCLC to immunotherapy;

研究设计

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

入排标准

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

入选标准

  • Patient undergoing thoracic surgery for a confirmed or suspected lung cancer

排除标准

  • Uncertainty of pre-operative diagnosis, exception is per-op frozen section analysis confirming malignity
  • Bleeding disorders

结局指标

主要结局

The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo

时间窗: 7 days following surgery

All adverse events will be classified by the Clavien Dindo classification. The study will be closed prematurely if 2 patients experience a grade 3 adverse event directly related to the bone marrow aspiration

次要结局

  • Measurement of the Amount of HPSC's That Can be Obtained From Costal Bone Marrow(7 days following aspiration from the bone marrow)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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