Gastric CancerNCT05901376
MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection
An observational study of Gastric Cancer and MicroRNAs, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, MicroRNAs
- What is being tested?
- MicroRNA
- How many people
- 280 participants
- Where
- 1 siteThailand
- Study dates
- 25 Apr 2023to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients who cannot give informed consent
- Pregnancy
- Lymphoma
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, Not Required For This Country, 10400
Rapat Pittayanon, MD, 022564000, rapat125@gmail.com
About this study
Official title: 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.
- Conditions
- Gastric Cancer, MicroRNAs
- Being tested
- MicroRNA
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroRNADiagnostic test
MiR-20a, MiR-21, MiR-106b, MiR-199a, MiR-223
| Study group | Role | What they receive |
|---|---|---|
| Gastric Cancer | Not described Receives: Diagnostic Test: MicroRNA | |
| Control | Not described Receives: Diagnostic Test: MicroRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The different of MiR-20a level between gastric cancer and control group
The different of MiR-20a level between gastric cancer and control group
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start25 Apr 2023
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901376
- Sponsor's protocol ID
- RP023
- Status last verified
- Jun 2023
- First submitted
- 29 Mar 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection: a Diagnostic Study
- ClinicalTrials.gov ID
- NCT05901376
- Acronym / sponsor ID
- RP023
- Conditions
- Gastric Cancer, MicroRNAs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Cancer | – | Diagnostic Test: MicroRNA |
| Control | – | Diagnostic Test: MicroRNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who cannot give informed consent
- Pregnancy
- Lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroRNAMiR-20a, MiR-21, MiR-106b, MiR-199a, MiR-223 | Diagnostic test | Control, Gastric Cancer |
Primary outcome
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and MicroRNAs, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rapat Pittayanon (+662564000, rapat125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The different of MiR-20a level between gastric cancer and control group (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.