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Use of Blood Biomarkers to Predict Gastric Cancer Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04329299
Recruitment Status : Completed
First Posted : April 1, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Tan Tock Seng Hospital
MiRXES Pte. Ltd., Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore

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.


Condition or disease Intervention/treatment
Stomach Neoplasm Diagnostic Test: blood-based biomarkers analyses

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Study Type : Observational
Actual Enrollment : 6862 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Blood Biomarkers to Predict Gastric Cancer Risk
Actual Study Start Date : December 3, 2012
Actual Primary Completion Date : May 29, 2016
Actual Study Completion Date : May 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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




Primary Outcome Measures :
  1. Gastric cancer [ Time Frame: 10 years ]
    Number of patients who develop gastric cancer, including high grade dysplasia, carcinoma in-situ and adenocarcinoma


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329299


Locations
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Singapore
National University Hospital, Singapore
Singapore, Singapore, 119074
Tan Tock Seng Hospital, Singapore
Singapore, Singapore, 308433
Sponsors and Collaborators
National University Hospital, Singapore
Tan Tock Seng Hospital
MiRXES Pte. Ltd., Singapore
Investigators
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Principal Investigator: Calvin Jianyi Koh, MBBS, MMed National University Hospital, Singapore
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT04329299    
Other Study ID Numbers: 2012/00737
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University Hospital, Singapore:
Gastric Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases