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临床试验/NCT03476057
NCT03476057Unknown不适用

Next-generation Sequencing in Gastrointestinal Cancer

Fujian Cancer Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
cfDNA

研究概览

简要总结

Liquid biopsy has been successfully applied to the treatment and diagnosis of cancer. cfDNA has been paid more and more attention in liquid biopsy. Previous studies have shown that cfDNA can be used for predicting the efficacy of radiotherapy or chemotherapy for lung cancer, rectal cancer and esophageal cancer. It is also reported that cfDNA can be used for the evaluation of postoperative recurrence of advanced gastric cancer. However, the use of NGS to detect cfDNA in gastrointestinal tumors has not been reported. The purpose of this study is to investigate the correlation between cfDNA, cfDNA tumor buden with advanced gastrointestinal tract tumor patients, and find out prognosis gene of advanced gastrointestinal tract tumor.

详细描述

Sample DNA handling: Peripheral blood lymphocytes (PBLs), and plasma were collected for analysis for each patient. 10mL tubes containing blood samples with EDTA added were centrifuged at 1000g for 10min. The cell pellets containing peripheral blood lymphocytes were stored at -20 °C. The supernatants were centrifuged again at 10,000 g for 10 min, and plasma was collected and stored at -80°C.Tiangen whole blood DNA Kit (Tiangen, Beijing, PRC) were used to extracted DNA from peripheral blood lymphocytes, respectively. QIAamp Circulating Nucleic Acid Kit (Qiagen, German) was used to extract cfDNA form plasma. All kits were used according to the manufacturers' instructions.

Library preparation and sequencing: For each sample, DNA was quantified with the Qubit dsDNA HS Assay kit (Life Technologies,USA) as manufacturer's recommended protocol. Targeted amplification and Illumina adapter-ligated library preparation was performed using Amplicon Sequencing-Illumina Compatible Kit following manufacturer's instructions (Questgenomics, Nanjing, PRC). All samples were subjected to Illumina HiSeq X-Ten for paired-end sequencing (150bp each end). The AmpliSeq Cancer Panel covers 1406 cancer-associated genes which developed by Co. Roche.

Variant calling: Initial data from HiSeq X-Ten were evaluated by using fastQC (v0.11.3). Raw reads were mapped to reference genome hg19 by using BWA (0.7.12-r1039). Program Samtools and VarScan (v2.4.1) was used for variant calling: (1) the average total coverage depth was defined as >1000 and each variant coverage as >10; for called variant, at least one sample with variant frequency >1%, variant frequency of each sample >0.5%, and P value <0.01; (2) visual examination of the mutations was performed using Samtools software (http://samtools.sourceforge.net) and possible errors specific to one DNA strand were filtered out. Software ANNOVAR (v2015-06-17) and snpEff (v4.2) was used for variant annotation

Statistical analysis: For variant frequency less than 0.5%, 0 was replaced. R (hclust, v3.2.4) was used for variant frequency clustering analysis to show what types of samples from cancer patients are more similar. Student's T test was applied for comparison of cfDNA concentration and p<0.05 was considered statistically significant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with pathologically confirmed Stage III/ IV gastrointestinal cancer
  • all patients had not received chemotherapy

排除标准

  • 未提供

结局指标

主要结局

cfDNA

时间窗: 6 months

demonstrates the spectrum of cfDNA alterations/ profiling

次要结局

  • Tumor mutation burden(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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