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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915171
• Other study ID #: RSTL2018011
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2019
• Source: China Medical University, China
• Contact: Yunpeng Liu, ph.D
• Phone: +86(0)24 961200
• Email: cmuliuyunpeng[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Intestinal Neoplasms

Intervention

Diagnostic Test:
• Next generation sequencing
NGS can provide genetic and MSI test for patients

Locations

Country	Name	City	State
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of blood MSI detected by NGS	To study the sensitivity and specificity of blood MSI detected by NGS.	1 year
Secondary	Ideal sequencing depth of MSI in blood test	To study the ideal sequencing depth of MSI in blood test.	1 year
Secondary	Correlation between MSI status and TMB	To study the correlation between MSI status and TMB.	1 year
Secondary	Correlation between MMR gene and other gene mutations	To study thecorrelation between MMR gene and other gene mutations.	1 year