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

NCT ID: NCT03915171

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-06-01

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MSI-H

IHC/PCR tested as dMMR/ MSI-H

Group Type EXPERIMENTAL

Next generation sequencing

Intervention Type DIAGNOSTIC_TEST

NGS can provide genetic and MSI test for patients

MSS

IHC/PCR tested as pMMR/ MSS

Group Type EXPERIMENTAL

Next generation sequencing

Intervention Type DIAGNOSTIC_TEST

NGS can provide genetic and MSI test for patients

Interventions

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Next generation sequencing

NGS can provide genetic and MSI test for patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yunpeng Liu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunpeng Liu, ph.D

Role: CONTACT

+86(0)24 961200

Xiujuan Qu

Role: CONTACT

+86(0)24 83282542

Facility Contacts

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Yunpeng Liu, Ph.D

Role: primary

Other Identifiers

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RSTL2018011

Identifier Type: -

Identifier Source: org_study_id

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