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

China Medical University, China

Status: Unknown

Conditions: Gastrointestinal Cancer

Treatments: Diagnostic Test: Next generation sequencing

Study type: Interventional

Funder types: Other

Identifiers

NCT03915171

RSTL2018011

Details and patient eligibility

About

To study the sensitivity and specificity of NGS in detecting Microsatellite State in blood and to evaluate its potential application in gastrointestinal cancer.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

MSI-H

Experimental group

Description:

IHC/PCR tested as dMMR/ MSI-H

Treatment:

Diagnostic Test: Next generation sequencing

MSS

Experimental group

Description:

IHC/PCR tested as pMMR/ MSS

Treatment:

Diagnostic Test: Next generation sequencing