Sensitivity and Specificity of NGS in Detecting bMSI in P... | NCT03915171

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

NCT03915171

Sponsor

China Medical University, China

Status

Unknown status

Last Update Posted

Apr 16, 2019Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Gastrointestinal Cancer

Interventions

Next generation sequencing

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Jun 1, 2020Estimated

First Submitted Date

Mar 25, 2019

First Submission Date that Met QC Criteria

Apr 12, 2019

First Posted Date

Apr 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSI-H	Experimental	IHC/PCR tested as dMMR/ MSI-H	Diagnostic Test: Next generation sequencing
MSS	Experimental	IHC/PCR tested as pMMR/ MSS	Diagnostic Test: Next generation sequencing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Next generation sequencing	Diagnostic Test	NGS can provide genetic and MSI test for patients	MSI-H MSS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of blood MSI detected by NGS	To study the sensitivity and specificity of blood MSI detected by NGS.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Ideal sequencing depth of MSI in blood test	To study the ideal sequencing depth of MSI in blood test.	1 year
Correlation between MSI status and TMB	To study the correlation between MSI status and TMB.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yunpeng Liu, ph.D	Contact	＋86(0)24 961200		cmuliuyunpeng@hotmail.com
Xiujuan Qu	Contact	＋86(0)24 83282542		qu_xiujuan@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of China Medical University	Recruiting	Shenyang	Liaoning	110001	China

Condition Browse Module

MeSH Terms

ID	Term
D005770	Gastrointestinal Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

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