Use of Blood Biomarkers to Predict Gastric Cancer Risk

NCT04329299 | Completed

• 1 other identifier: 2012/00737
• Study Type: observational
• Target: 6,862
• Locations: 1 country
• Sites: 2

Brief Summary

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

Stomach Neoplasm

Keywords

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Gastric cancer

  Number of patients who develop gastric cancer, including high grade dysplasia, carcinoma in-situ and adenocarcinoma

  10 years

Study Arms (1)

Blood Biomarkers Analyses

15 ml of blood sample will be obtained from each study participant, for blood-based biomarkers analyses.

Diagnostic Test: blood-based biomarkers analyses

Interventions

blood-based biomarkers analyses DIAGNOSTIC_TEST

Analyses of H. pylori antibodies/pepsinogen levels, micro RNAs (miRNAs) or blood-based protein markers levels in participants' blood samples

Blood Biomarkers Analyses

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been referred to the participating study sites for upper GI endoscopy for standard clinical indications.

You may qualify if:

• The subject is greater than 40 years of age.
• The subject is scheduled to undergo an endoscopy because of medical indication.
• 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.
• The subject must be willing and able to comply with all study procedures.

You may not qualify if:

• The subject who is unable to undergo gastroscopy.
• The subject with previous total or partial gastrectomy.
• 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.
• The subject is unwilling or unable to provide signed informed consent.
• The subject who is pregnant.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Tan Tock Seng Hospital: collaborator
• MiRXES Pte Ltd: collaborator

Study Sites (2)

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

Tan Tock Seng Hospital, Singapore

Singapore, 308433, Singapore

Location

Related Publications (6)

• Dan 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 BACKGROUND

• Miki 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 BACKGROUND

• Cortez 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 BACKGROUND

• Song 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 BACKGROUND

• So 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 DERIVED

• Bibault 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

15 ml of Blood sample collected from each study participant, will be processed to extract serum, plasma and white blood cells.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Calvin Jianyi Koh, MBBS, MMed

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: December 3, 2012
• Primary Completion: May 29, 2016
• Study Completion: May 29, 2016
• Last Updated: October 22, 2020

Record last verified: 2020-03

Locations

SG (2)