NCT05901376

Brief Summary

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.

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
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

March 29, 2023

Last Update Submit

June 3, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • The different of MiR-20a level between gastric cancer and control group

    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

    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

    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

    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

    The different of MiR-223 level between gastric cancer and control group

    Day 1

Study Arms (2)

Gastric Cancer

Diagnostic Test: MicroRNA

Control

Diagnostic Test: MicroRNA

Interventions

MicroRNADIAGNOSTIC_TEST

MiR-20a, MiR-21, MiR-106b, MiR-199a, MiR-223

ControlGastric Cancer

Eligibility Criteria

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

You may qualify if:

  • Recently diagnosed gastric cancer
  • Never received any treatment for gastric cancer
  • Age 50 or above
  • Underwent elective upper gastrointestinal endoscopy and negative for gastric cancer
  • No prior history of gastric dysplasia or cancer

You may not qualify if:

  • Patients who cannot give informed consent
  • Pregnancy
  • Lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Not Required For This Country, 10400, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

5 cc of blood will be obtained from each subject then the plasma portion will be collected.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Rapat Pittayanon

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2023

First Posted

June 13, 2023

Study Start

April 25, 2023

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations