Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Cancer | Diagnostic Test: Next generation sequencing | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer |
Actual Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | December 1, 2019 |
Estimated Study Completion Date : | June 1, 2020 |
Arm | Intervention/treatment |
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Experimental: MSI-H
IHC/PCR tested as dMMR/ MSI-H
|
Diagnostic Test: Next generation sequencing
NGS can provide genetic and MSI test for patients
|
Experimental: MSS
IHC/PCR tested as pMMR/ MSS
|
Diagnostic Test: Next generation sequencing
NGS can provide genetic and MSI test for patients
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yunpeng Liu, ph.D | +86(0)24 961200 | cmuliuyunpeng@hotmail.com | |
Contact: Xiujuan Qu | +86(0)24 83282542 | qu_xiujuan@hotmail.com |
China, Liaoning | |
The First Affiliated Hospital of China Medical University | Recruiting |
Shenyang, Liaoning, China, 110001 | |
Contact: Yunpeng Liu, Ph.D |
Tracking Information | |||||
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First Submitted Date ICMJE | March 25, 2019 | ||||
First Posted Date ICMJE | April 16, 2019 | ||||
Last Update Posted Date | April 16, 2019 | ||||
Actual Study Start Date ICMJE | March 1, 2019 | ||||
Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Sensitivity and specificity of blood MSI detected by NGS [ Time Frame: 1 year ] To study the sensitivity and specificity of blood MSI detected by NGS.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer | ||||
Official Title ICMJE | Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer | ||||
Brief Summary | To study the sensitivity and specificity of NGS in detecting Microsatellite State in blood and to evaluate its potential application in gastrointestinal cancer. | ||||
Detailed Description | NGS can not only detect tissue samples, but also blood samples. For some inoperable cancer patients, the acquisition of tissue samples is difficult and traumatic. It is of great significance for the diagnosis and treatment of these patients to determine MSI status by blood testing. In addition, the heterogeneity of malignant tumors is usually strong, blood testing can overcome the heterogeneity of tissue, and can dynamically monitor the patient's condition. 50 patients with gastric cancer, duodenal cancer and small intestinal cancer will be enrolled in the study. Among them, 30 patients with MSI-H and 20 patients with MSS confirmed by IHC/PCR.The investigators will use 520 gene panel for NGS sequencing of tissue and blood samples from selected patients to study the sensitivity and specificity of NGS in detecting Microsatellite State in blood. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Gastrointestinal Cancer | ||||
Intervention ICMJE | Diagnostic Test: Next generation sequencing
NGS can provide genetic and MSI test for patients
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 1, 2020 | ||||
Estimated Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03915171 | ||||
Other Study ID Numbers ICMJE | RSTL2018011 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Yunpeng Liu, China Medical University, China | ||||
Study Sponsor ICMJE | China Medical University, China | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | China Medical University, China | ||||
Verification Date | April 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |