Gastrointestinal Cancer
Conditions
Keywords
NGS bMSI Gastrointestinal
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.
Interventions
DIAGNOSTIC_TESTNext generation sequencing
NGS can provide genetic and MSI test for patients
Sponsors
China Medical University, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of blood MSI detected by NGS | 1 year | To study the sensitivity and specificity of blood MSI detected by NGS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYunpeng Liu, ph.D
Backup ContactXiujuan Qu
Outcome results
None listed