Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer

Sponsor

China Medical University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT03915171

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer	Diagnostic Test: Next generation sequencing	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity of blood MSI detected by NGS [1 year]
To study the sensitivity and specificity of blood MSI detected by NGS.

Secondary Outcome Measures

Ideal sequencing depth of MSI in blood test [1 year]
To study the ideal sequencing depth of MSI in blood test.
Correlation between MSI status and TMB [1 year]
To study the correlation between MSI status and TMB.
Correlation between MMR gene and other gene mutations [1 year]
To study thecorrelation between MMR gene and other gene mutations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China	110001

Sponsors and Collaborators

China Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yunpeng Liu, Director, China Medical University, China

ClinicalTrials.gov Identifier:

NCT03915171

Other Study ID Numbers:

RSTL2018011

First Posted:

Apr 16, 2019

Last Update Posted:

Apr 16, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yunpeng Liu, Director, China Medical University, China

NGS bMSI Gastrointestinal

Additional relevant MeSH terms:

Gastrointestinal Neoplasms

Intestinal Neoplasms

Study Results

No Results Posted as of Apr 16, 2019