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

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ClinicalTrials.gov Identifier: NCT03915171
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Yunpeng Liu, China Medical University, China

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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




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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915171


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

Locations
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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

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Responsible Party: Yunpeng Liu, Director, China Medical University, China
ClinicalTrials.gov Identifier: NCT03915171     History of Changes
Other Study ID Numbers: RSTL2018011
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yunpeng Liu, China Medical University, China:
NGS bMSI Gastrointestinal

Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases