跳至主要内容
临床试验/NCT04691284
NCT04691284招募中不适用

Microbiome in Cancer Patients Undergoing High Dose Chemotherapy With Stem Cell Transplantation

National Cancer Institute, Slovakia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Microbial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation and CAR-T cell therapy

研究概览

简要总结

Numerous in vitro and animal studies as well as growing number of clinical studies support the important role of microbiome in carcinogenesis and cancer treatment. Detection of changes in patients´ microbiome following hematopoietic cell transplantation/CAR-T cell therapy and correlations with adverse transplant outcomes, mainly infectious complications, acute and chronic GvHD, disease recurrence etc. could serve as predictive markers of immune recovery and treatment response.

详细描述

Currently, available findings coming mainly from allo-HSCT (hhematopoietic cell transplantation) studies, link particular changes in microbiota with overall survival and post-transplant disorders, especially GvHD. According to limited data, further evaluation of associations between the alterations in microbiome composition and toxicities. Detail investigation of both the microbiome and host immune system may help to find microbiome markers useful for very early identification of patients at risk for major transplant-related complications. This might bring the possibility to modulate the gut microbiota in patient´s specific manner to achieve optimal therapeutic outcome and follow-up, while avoiding severe post-transplant complications.

This is prospective, single center, non-randomized, hypothesis generating study. Patients will be asked to provide a sample of blood, urine and stool. This blood will be used for plasma and serum banking for further analysis, including micro RNA (miR) and chemokine detection. Stool will be used for microbiome studies - isolation of total DNA/RNA and 16S (RNA component of the small subunit of a prokaryotic ribosome) rRNA (ribosomal ribonucleic acid) gene sequencing for bacterial taxonomic classification. Furthermore, metagenomic sequencing and subsequent taxonomic and functional classification of microbial genes will be used including characterization of potentially clinically relevant features of the microbiome such as antibiotic resistance and microbial virulence factors.

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

  • signed written informed consent
  • aged 18 years or older
  • patients planned to be treated by high-dose chemotherapy and hematopoietic cell transplantation or by CAR-T cell therapy in National Cancer Institute, Slovakia

排除标准

  • patients not-matching inclusion criteria

结局指标

主要结局

Microbial changes in stool as measured by 16S rRNA gene sequencing in hematological cancer patients before, at time and after hematopoietic cell transplantation and CAR-T cell therapy

时间窗: 100 days

Microbial changes of stool will be assessed before, at time and after hematopoietic cell transplantation and CAR-T cell therapy

次要结局

  • To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients nutrition status(100 days)
  • To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the post-transplant complications in auto and allogeneic transplant settings (GvHD, diarrhea, infectious complications) and in CAR-T cell therapy(100 days)
  • To correlate microbial changes in stool as measured by 16S rRNA gene sequencing with the patients reported outcomes.(100 days)

研究者

发起方
National Cancer Institute, Slovakia
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Microbiome in Cancer Patients With High Dose... | 临床试验