4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer

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

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 Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 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

Outcome Measures
Primary Outcome Measures :
  1. Sensitivity and specificity of blood MSI detected by NGS [ Time Frame: 1 year ]
    To study the sensitivity and specificity of blood MSI detected by NGS.


Secondary Outcome Measures :
  1. Ideal sequencing depth of MSI in blood test [ Time Frame: 1 year ]
    To study the ideal sequencing depth of MSI in blood test.

  2. Correlation between MSI status and TMB [ Time Frame: 1 year ]
    To study the correlation between MSI status and TMB.

  3. Correlation between MMR gene and other gene mutations [ Time Frame: 1 year ]
    To study thecorrelation between MMR gene and other gene mutations.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts
Layout table for location contacts
Contact: Yunpeng Liu, ph.D +86(0)24 961200 cmuliuyunpeng@hotmail.com
Contact: Xiujuan Qu +86(0)24 83282542 qu_xiujuan@hotmail.com

Locations
Layout table for location information
China, Liaoning
The First Affiliated Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Yunpeng Liu, Ph.D         
Sponsors and Collaborators
China Medical University, China
Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
Sensitivity and specificity of blood MSI detected by NGS [ Time Frame: 1 year ]
To study the sensitivity and specificity of blood MSI detected by NGS.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • Ideal sequencing depth of MSI in blood test [ Time Frame: 1 year ]
    To study the ideal sequencing depth of MSI in blood test.
  • Correlation between MSI status and TMB [ Time Frame: 1 year ]
    To study the correlation between MSI status and TMB.
  • Correlation between MMR gene and other gene mutations [ Time Frame: 1 year ]
    To study thecorrelation between MMR gene and other gene mutations.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
Official Title  ICMJE Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Gastrointestinal Cancer
Intervention  ICMJE Diagnostic Test: Next generation sequencing
NGS can provide genetic and MSI test for patients
Study Arms  ICMJE
  • Experimental: MSI-H
    IHC/PCR tested as dMMR/ MSI-H
    Intervention: Diagnostic Test: Next generation sequencing
  • Experimental: MSS
    IHC/PCR tested as pMMR/ MSS
    Intervention: Diagnostic Test: Next generation sequencing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03915171
Other Study ID Numbers  ICMJE RSTL2018011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yunpeng Liu, China Medical University, China
Study Sponsor  ICMJE China Medical University, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account China Medical University, China
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP