MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection

June 3, 2023 updated by: Rapat Pittayanon, King Chulalongkorn Memorial Hospital

MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection: a Diagnostic Study

The goal of this observational study is to compare specific microRNA levels from the plasma of gastric cancer patients and healthy volunteers to see if there is an upregulated expression in gastric cancer patients.

The main question it aims to answer is:

- Can microRNAs be effectively used as diagnostic biomarkers for gastric cancer?

Participants will be asked for their consent to obtain 5 cc of blood.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Not Required For This Country
      • Bangkok, Not Required For This Country, Thailand, 10400
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients from King Chulalongkorn Memorial Hospital

Inclusion Criteria for Gastric Cancer group:

  • Recently diagnosed gastric cancer
  • Never received any treatment for gastric cancer

Inclusion Criteria for Control group:

  • Age 50 or above
  • Underwent elective upper gastrointestinal endoscopy and negative for gastric cancer
  • No prior history of gastric dysplasia or cancer

Exclusion Criteria:

  • Patients who cannot give informed consent
  • Pregnancy
  • Lymphoma

Description

Inclusion Criteria for Gastric Cancer group:

  • Recently diagnosed gastric cancer
  • Never received any treatment for gastric cancer

Inclusion Criteria for Control group:

  • Age 50 or above
  • Underwent elective upper gastrointestinal endoscopy and negative for gastric cancer
  • No prior history of gastric dysplasia or cancer

Exclusion Criteria:

  • Patients who cannot give informed consent
  • Pregnancy
  • Lymphoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Diagnostic test: MicroRNA
MiR-20a, MiR-21, MiR-106b, MiR-199a, MiR-223
Gastric Cancer
Diagnostic test: MicroRNA
MiR-20a, MiR-21, MiR-106b, MiR-199a, MiR-223

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The different of MiR-20a level between gastric cancer and control group
Time Frame: Day 1
The different of MiR-20a level between gastric cancer and control group
Day 1
The different of MiR-21 level between gastric cancer and control group
Time Frame: Day 1
The different of MiR-21 level between gastric cancer and control group
Day 1
The different of MiR-106b level between gastric cancer and control group
Time Frame: Day 1
The different of MiR-106b level between gastric cancer and control group
Day 1
The different of MiR-199a level between gastric cancer and control group
Time Frame: Day 1
The different of MiR-199a level between gastric cancer and control group
Day 1
The different of MiR-223 level between gastric cancer and control group
Time Frame: Day 1
The different of MiR-223 level between gastric cancer and control group
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Chulalongkorn Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

June 3, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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