此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Clinical Application of Liquid Biopsy for Precise Diagnosis and Prognosis in Lymphoma

2022年3月22日 更新者：Ge Zheng

Clinical Transformation Application and Technology Research in Liquid Biopsy for Precise Diagnosis and Prognosis of Lymphoma

Lymphoma is a highly heterogeneous blood malignancy. It is very important to search for relative specific diagnostic markers that can detect related lymphoma in early stage for the treatment and long-term prognosis of the disease, as the hematopoietic diseases, such as lymphoma, are more difficult to biopsy than solid tumors, with more damage and side effects.Liquid Biopsy (Liquid Biopsy) refers to the extraction of solid biological tissue, is the most common blood, also including saliva, urine, cerebrospinal fluid and other body fluids, and extract the circulating tumor cells (circulating tumor cell, CTC) and circulating tumor DNA (circulating tumor DNA, ctDNA) is used to assess related diseases. CTCs/CSCs have the ability to generate new tumors and play a key role in tumor metastasis.This project intends to develop liquid biopsy technology for accurate diagnosis and prognosis judgment of lymphoma, to carry out clinical transformation application and serve patients.

研究概览

地位

完全的

条件

详细说明

  1. Patients with series and matched lymphoma who were refractory to initial diagnosis, remission and recurrence were enrolled, our research group will collected patient information comprehensively and signed the informed consent.
  2. The standard diagnosis process and treatment selection will be completed, and our research group willcollect relevant clinical and laboratory data.
  3. 5 ml of peripheral blood from each patient was collected with EDTA anticoagulant tube, and the blood cells were centrifuged at 820×g for 10 min at 4℃ within 1 h to separate the blood cells.The plasma was then transferred to a microcentrifuge tube and centrifuged at 4℃ at 20,000×g for 10 min to remove cell debris.According to the reagent instructions, cfDNA was extracted from 2 ml cell-free plasma and the concentration of cfDNA in each patient was determined.Meanwhile, genomic DNA kit was used to extract matching tumor DNA from lymphoma bone marrow tissue.
  4. We will extract the lymphoma of bone marrow tissue samples of RNA, and reverse transcription for cDNA, the use of qRT PCR verifying the mutations in tissue samples, after identifying the lymphoma five of the most common mutations from the cancer genome map (TCGA;http://cancergenome.nih.gov/) .
  5. The differences of mutations detected by liquid biopsy and tumor in situ biopsy will be compared, by NGS sequencing of peripheral blood cfDNA and lymphoma tissue DNA. Meanwhile, the mutation rate of each gene mutation was analyzed for lymphoma tissue type.
  6. The classification and malignant changes of matched lymphomas were statistically analyzed to study the differences in cfDNA concentration of different types of lymphomas, according to the cfDNA concentration determined at the earlier stage.
  7. The mutation differences of cfDNA in the peripheral blood of each patient will be compared at three time points before, during and after treatment, combined with PET/CT detection, and the correlation between cfDNA detection indexes and therapeutic effect and prognosis monitoring will be evaluated.
  8. SPSS 23.0 statistical software would be used to evaluate the correlation between cfDNA concentration in lymphoma and disease staging, grouping, subtype, efficacy prediction and recurrence monitoring. P<0.05 was considered statistically significant.

研究类型

观察性的

注册 (实际的)

60

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。

学习地点

  • 中国
    • Jiangsu
      • NanJing、Jiangsu、中国、210000
        • Institute of Hematology Southeast University Department of Hematology Zhongda Hospital Southeast University Medical School

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment, aged between 14 to 75 years.

描述

Inclusion Criteria:

  • patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment

Exclusion Criteria:

  • leukemia

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

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
complete remission
大体时间：From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks
Patients achieve complete remission after initial treatment
From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks
relapse
大体时间：From date of randomization or complete remission until the date of first documented relapse from any cause，assessed up to 100weeks.
Patients' disease progress after complete remission
From date of randomization or complete remission until the date of first documented relapse from any cause，assessed up to 100weeks.

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。

赞助

Ge Zheng

调查人员

  • 研究主任：Zheng Ge、Director of Department of Hematology Zhongda Hospital

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 (实际的)

2018年7月1日

初级完成 (实际的)

2021年12月30日

研究完成 (实际的)

2021年12月30日

研究注册日期

首次提交

2019年8月5日

首先提交符合 QC 标准的

2019年8月18日

首次发布 (实际的)

2019年8月20日

研究记录更新

最后更新发布 (实际的)

2022年3月24日

上次提交的符合 QC 标准的更新

2022年3月22日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ZDYYGZ201907

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Russia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅