NCT03915171

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

March 25, 2019

Last Update Submit

April 12, 2019

Conditions

Gastrointestinal Cancer

Keywords

NGS bMSI Gastrointestinal

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Ideal sequencing depth of MSI in blood test

    1 year

  • Correlation between MSI status and TMB

    1 year

  • Correlation between MMR gene and other gene mutations

    1 year

Study Arms (2)

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

Next generation sequencingDIAGNOSTIC_TEST

NGS can provide genetic and MSI test for patients

MSI-HMSS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Suffering from other malignant tumors at the same time.
  • Others that the investigator consider that is inappropriate for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Yunpeng Liu, ph.D

CONTACT

＋86(0)24 961200cmuliuyunpeng@hotmail.com

Xiujuan Qu

CONTACT

＋86(0)24 83282542qu_xiujuan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 16, 2019

Study Start

March 1, 2019

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

CN(1)