MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection

• Sponsor: King Chulalongkorn Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05901376
• Collaborator: (none)
• Enrollment: 280
• Location: 1
• Anticipated Duration (Months): 25.2
• Patients Per Site Per Month: 11.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer; MicroRNAs	Diagnostic Test: MicroRNA

Study Design

• Study Type: Observational
• Anticipated Enrollment: 280 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection: a Diagnostic Study
• Actual Study Start Date: Apr 25, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Gastric Cancer	Diagnostic Test: MicroRNA; MiR-20a, MiR-21, MiR-106b, MiR-199a, MiR-223
Control	Diagnostic Test: MicroRNA; MiR-20a, MiR-21, MiR-106b, MiR-199a, MiR-223

Outcome Measures

Primary Outcome Measures

1. The different of MiR-20a level between gastric cancer and control group [Day 1]

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

2. The different of MiR-21 level between gastric cancer and control group [Day 1]

   The different of MiR-21 level between gastric cancer and control group

3. The different of MiR-106b level between gastric cancer and control group [Day 1]

   The different of MiR-106b level between gastric cancer and control group

4. The different of MiR-199a level between gastric cancer and control group [Day 1]

   The different of MiR-199a level between gastric cancer and control group

5. The different of MiR-223 level between gastric cancer and control group [Day 1]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Chulalongkorn Memorial Hospital	Bangkok	Not Required For This Country	Thailand	10400

Sponsors and Collaborators

• King Chulalongkorn Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rapat Pittayanon, Associate Professor, King Chulalongkorn Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05901376
• Other Study ID Numbers: RP023
• First Posted: Jun 13, 2023
• Last Update Posted: Jun 13, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Jun 13, 2023