Clinical trial · Observational
Use of Blood Biomarkers to Predict Gastric Cancer Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to develop a cost-effective screening strategy for the Singapore population by targeted screening of people who have a high risk of stomach cancer, in order to detect early signs of the disease at a stage that can be prevented or cured. Often, patients only consult their doctors when they have advanced symptoms, by which time the cancer may be at a difficult to treat, or incurable stage. Using costs in the Singapore health system as well as local population risk profiles and demographics, our previous study demonstrated that screening of high-risk groups is cost-effective and a panel of serum makers was effective in differentiating high-risk from low-risk individuals. This study aims to validate the predictive value of various blood biomarkers, such as that of antibodies against Helicobacter pylori, pepsinogen levels, micro RNAs (miRNAs) and blood-based protein markers in participants who have been scheduled to undergo upper gastrointestinal (GI) endoscopy for clinical reasons. If successful, the marker can be used to stratify population into different risk groups and various screening systems can be provided according to different risk level. This will reduce the number of annual invasive screening examinations required to detect early gastric cancer (GC), thereby rendering it cost-effective to generalize as clinical practice in Singapore.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood-based biomarkers analyses | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Blood Biomarkers Analyses
- description
- 15 ml of blood sample will be obtained from each study participant, for blood-based biomarkers analyses.
- interventionNames
- Diagnostic Test: blood-based biomarkers analyses
Primary outcomes (1)
- measure
- Gastric cancer
- timeFrame
- 10 years
- description
- Number of patients who develop gastric cancer, including high grade dysplasia, carcinoma in-situ and adenocarcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject is greater than 40 years of age. 2. The subject is scheduled to undergo an endoscopy because of medical indication. 3. The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study. 4. The subject must be willing and able to comply with all study procedures. Exclusion Criteria: 1. The subject who is unable to undergo gastroscopy. 2. The subject with previous total or partial gastrectomy. 3. The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study. 4. The subject is unwilling or unable to provide signed informed consent. 5. The subject who is pregnant.
References
Publications (6)
- BACKGROUNDDan YY, So JB, Yeoh KG. Endoscopic screening for gastric cancer. Clin Gastroenterol Hepatol. 2006 Jun;4(6):709-16. doi: 10.1016/j.cgh.2006.03.025. PMID 16765306
- BACKGROUNDMiki K. Gastric cancer screening by combined assay for serum anti-Helicobacter pylori IgG antibody and serum pepsinogen levels - "ABC method". Proc Jpn Acad Ser B Phys Biol Sci. 2011;87(7):405-14. doi: 10.2183/pjab.87.405. PMID 21785258
- BACKGROUNDCortez MA, Bueso-Ramos C, Ferdin J, Lopez-Berestein G, Sood AK, Calin GA. MicroRNAs in body fluids--the mix of hormones and biomarkers. Nat Rev Clin Oncol. 2011 Jun 7;8(8):467-77. doi: 10.1038/nrclinonc.2011.76. PMID 21647195
- BACKGROUNDSong JH, Meltzer SJ. MicroRNAs in pathogenesis, diagnosis, and treatment of gastroesophageal cancers. Gastroenterology. 2012 Jul;143(1):35-47.e2. doi: 10.1053/j.gastro.2012.05.003. Epub 2012 May 10. PMID 22580099
- DERIVEDSo JBY, Kapoor R, Zhu F, Koh C, Zhou L, Zou R, Tang YC, Goo PCK, Rha SY, Chung HC, Yoong J, Yap CT, Rao J, Chia CK, Tsao S, Shabbir A, Lee J, Lam KP, Hartman M, Yong WP, Too HP, Yeoh KG. Development and validation of a serum microRNA biomarker panel for detecting gastric cancer in a high-risk population. Gut. 2021 May;70(5):829-837. doi: 10.1136/gutjnl-2020-322065. Epub 2020 Oct 7. PMID 33028667
- DERIVEDBibault JE, Chang DT, Xing L. Development and validation of a model to predict survival in colorectal cancer using a gradient-boosted machine. Gut. 2021 May;70(5):884-889. doi: 10.1136/gutjnl-2020-321799. Epub 2020 Sep 4. PMID 32887732