Back to resultsSensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
Primary Purpose
Gastrointestinal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Next generation sequencing
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Cancer focused on measuring NGS bMSI Gastrointestinal
Eligibility Criteria
Inclusion Criteria:
- Age (>18 years old).
- Histologically diagnosed as gastric cancer, duodenal cancer or small intestinal cancer (stage III, stage IV).
- The status of dMMR/pMMR was confirmed by IHC/PCR.
- with tissue and blood samples (including ctDNA and white blood cells) that meet the requirements.
- Agree to provide demographic, medical history, pathological diagnosis, imaging diagnosis, TNM staging, ECOG score and other information.
Exclusion Criteria:
- Suffering from other malignant tumors at the same time.
- Others that the investigator consider that is inappropriate for this study.
Sites / Locations
- The First Affiliated Hospital of China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MSI-H
MSS
Arm Description
IHC/PCR tested as dMMR/ MSI-H
IHC/PCR tested as pMMR/ MSS
Outcomes
Primary Outcome Measures
Sensitivity and specificity of blood MSI detected by NGS
To study the sensitivity and specificity of blood MSI detected by NGS.
Secondary Outcome Measures
Ideal sequencing depth of MSI in blood test
To study the ideal sequencing depth of MSI in blood test.
Correlation between MSI status and TMB
To study the correlation between MSI status and TMB.
Correlation between MMR gene and other gene mutations
To study thecorrelation between MMR gene and other gene mutations.
Full Information
NCT ID
NCT03915171
First Posted
March 25, 2019
Last Updated
April 12, 2019
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT03915171
Brief Title
Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
Official Title
Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
NGS bMSI Gastrointestinal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MSI-H
Arm Type
Experimental
Arm Description
IHC/PCR tested as dMMR/ MSI-H
Arm Title
MSS
Arm Type
Experimental
Arm Description
IHC/PCR tested as pMMR/ MSS
Intervention Type
Diagnostic Test
Intervention Name(s)
Next generation sequencing
Intervention Description
NGS can provide genetic and MSI test for patients
Primary Outcome Measure Information:
Title
Sensitivity and specificity of blood MSI detected by NGS
Description
To study the sensitivity and specificity of blood MSI detected by NGS.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Ideal sequencing depth of MSI in blood test
Description
To study the ideal sequencing depth of MSI in blood test.
Time Frame
1 year
Title
Correlation between MSI status and TMB
Description
To study the correlation between MSI status and TMB.
Time Frame
1 year
Title
Correlation between MMR gene and other gene mutations
Description
To study thecorrelation between MMR gene and other gene mutations.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age (>18 years old).
Histologically diagnosed as gastric cancer, duodenal cancer or small intestinal cancer (stage III, stage IV).
The status of dMMR/pMMR was confirmed by IHC/PCR.
with tissue and blood samples (including ctDNA and white blood cells) that meet the requirements.
Agree to provide demographic, medical history, pathological diagnosis, imaging diagnosis, TNM staging, ECOG score and other information.
Exclusion Criteria:
Suffering from other malignant tumors at the same time.
Others that the investigator consider that is inappropriate for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunpeng Liu, ph.D
Phone
＋86(0)24 961200
Email
cmuliuyunpeng@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiujuan Qu
Phone
＋86(0)24 83282542
Email
qu_xiujuan@hotmail.com
Facility Information:
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunpeng Liu, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
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