A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules
Gastrointestinal Stromal Tumors (GIST) is the most common mesenchymal tumor of the gastrointestinal tract, and the incidence rate in China has increased year by year in recent years.Gastrointestinal stromal tumors are not sensitive to radiotherapy and traditional infusion chemotherapy.
Currently, they are generally treated with surgery, but they are prone to recurrence and metastasis.For nodules with a particle size between 2 and 5 cm, there may be both benign and malignant, and there is still a lack of fast and accurate methods for distinguishing benign and malignant.Many benign nodules were removed (in the pathological examination of postoperative resected tissue).
In addition, if it is found to be late, there is a possibility of invading surrounding tissues and metastasis, so that it is impossible to cure.
Therefore, early diagnosis and early surgery and benign and malignant differentiation of small nodules are the key to the clinical diagnosis and treatment of gastrointestinal stromal tumors.At present, second-generation gene sequencing (NGS) and liquid biopsy are rarely reported in the field of GIST.
A few domestic and foreign studies have found that it can detect rare mutation types, and may find secondary gene mutations early, which has potential applicability, but Overall, the clinical guidance of these NGS-based studies focuses on prognosis and drug resistance , as well as some studies based on low-throughput platforms.
Therefore, early diagnosis and benign and malignant discrimination based on high-throughput sequencing and liquid biopsy have significant clinical significance for the diagnosis and treatment of gastrointestinal stromal tumors.
研究概览
地位
未知
条件
干预/治疗
- 其他:DNA extraction of tumer tissue samples and high-throughput sequencing of small panels
- 其他:DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
- 其他:DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels
研究类型
观察性的
注册 (预期的)
300
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
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Jiangsu
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Nanjing、Jiangsu、中国、210029
- 招聘中
- First Affiliated Hospital of Nanjing Medical University
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接触:
- Xiqiao none Zhou, doctor
- 电话号码:13951826318
- 邮箱:Xiqiao_zhou@126.com
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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
Gastrointestinal stromal tumor patients in Jiangsu Provincial People's Hospital
描述
Inclusion Criteria:
- Patients who are scheduled for stromal tumor resection
- Signed informed consent
Exclusion Criteria:
- the vital signs are not stable
- unconscious
- unwilling to cooperate
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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The construction of Gene detection technology flow
At this stage, a small panel targeted high-throughput sequencing process for gastrointestinal stromal tumors was established, and the association of tumor-associated mutation profiles in different patients with clinical stage was initially explored.
It is planned to collect about 100 cases of gastrointestinal stromal tumors after surgery (freezing tissue or FFPE sections), DNA extraction and high-throughput sequencing of small panels, and analysis of the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging).
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DNA extraction of stromal tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed
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Establishment of non-invasive gene testing technology process
In this stage, we plan to establish a small panel of peripheral blood cfDNA targeting high-throughput sequencing process, and verify the consistency of peripheral blood cfDNA and tissue gDNA in gene detection of gastrointestinal stromal tumors.
About 50 patients were planned to be enrolled.
Peripheral blood was collected once for each patient and the blood volume was 10mL.
Meanwhile, the tumor tissue samples were collected within 5mm in diameter, depending on the size of the lesion .
DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood cfDNA and tissue gDNA for the gene detection of gastrointestinal stromal tumor.
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DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood cfDNA and tissue gDNA for the gene detection of gastrointestinal stromal tumor
DNA extraction and small panel sequencing were conducted for each patient sample.
Based on the indicator results of the previous mutant spectrum for each stage of gastrointestinal stromal tumor, the clinical stage classification of patients and the benign and malignant nodules were determined by the mutant spectrum, and compared with the real clinical data of patients
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Prospective cohort (double-blind recommended)
Peripheral blood of about 150 patients was collected once and the blood volume was 10mL .
Meanwhile, the tumor tissue samples were collected within 5mm in diameter, depending on the size of the lesion.
Patients focus on the early stage of stromal tumors or those whose size under gastroenteroscopy is between 2 and 5 cm.
DNA extraction and small panel sequencing were conducted for each patient sample.
Based on the indicator results of the previous mutation spectrum for each stage of gastrointestinal stromal tumor, the clinical stage classification of patients and the benign and malignant nodules were determined by the mutation spectrum, and compared with the real clinical data of patients.
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DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood cfDNA and tissue gDNA for the gene detection of gastrointestinal stromal tumor
DNA extraction and small panel sequencing were conducted for each patient sample.
Based on the indicator results of the previous mutant spectrum for each stage of gastrointestinal stromal tumor, the clinical stage classification of patients and the benign and malignant nodules were determined by the mutant spectrum, and compared with the real clinical data of patients
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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 |
|---|---|---|
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Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
大体时间:2019.8-2019.10
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DNA extraction of tumer tissue samples ,Preliminary exploration of tumor related mutation spectrum in different patients by gene sequencing
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2019.8-2019.10
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Genetic mutations of patients with stromal tumor assessed by next-generation sequencing
大体时间:2019.11-2020.5
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DNA extraction of tumer tissue samples and blood tissue .To evaluate the consistency of peripheral blood cfDNA and tissue gDNA in gene detection of gastrointestinal stromal tumors,Using mutational spectra to determine the clinical stage of the patient and the benign and malignant small nodules
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2019.11-2020.5
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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。
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)
2019年9月1日
初级完成 (预期的)
2020年5月31日
研究完成 (预期的)
2020年5月31日
研究注册日期
首次提交
2019年10月18日
首先提交符合 QC 标准的
2019年10月27日
首次发布 (实际的)
2019年10月29日
研究记录更新
最后更新发布 (实际的)
2020年5月11日
上次提交的符合 QC 标准的更新
2020年5月8日
最后验证
2020年5月1日
更多信息
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.