Multi-omics Analyses on Etiology and Early Detection of Stomach Cancer Precursor Lesions

February 20, 2024 updated by: Weimin Ye, Karolinska Institutet

Multi-omics Approach for Identification of Etiopathogenesis and Early Detection Biomarkers of Stomach Cancer Precursor Lesions

The overall aim is to utilize multi-omics approach to identify novel etiopathogenesis and early detection biomarkers for stomach cancer precursor lesions. To achieve this aim, first the investigators will use stored serum samples to perform metabolomics profiling among 12,599 twin subjects, among whom 1034 were deemed to have chronic atrophic gastritis based on measured pepsinogen I and II levels. Logistic regression will be used to search for metabolites related to the risk of chronic atrophic gastritis. Second, the investigators will further measure serum proteome by using two quantitatively precise proteomics assays, among the above-mentioned twin subjects. Identified protein biomarkers will be combined with metabolomics biomarkers to create a prediction model for chronic atrophic gastritis. The results will hopefully improve our understanding of the etiological factors and provide promising early detection biomarkers for stomach cancer precursor lesions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study population is part of the Swedish Twin Registry (STR), which has since its establishment in the late 1950s collected questionnaire data from all twins born after 1886. The data in this specific study is a subset of the Screening Across the Lifespan (SALT) study within the STR, in which all twins born between 1911-1958 were interviewed between 1998-2002. The subcohort named TwinGene was set-up between the years 2004 and 2008 when participants were invited to respond to a questionnaire on common diseases and provide a blood sample. Samples were collected from 12,618 twins born 1958 or earlier, of which blood sample from 12,609 were available. After excluding 10 samples which were unable to link to the available environmental data, a total of 12,599 blood samples were analyzed. Corpus-dominant CAG was characterized by a PGI/PGII ratio of less than 3. Metabolomic profiling using serum samples has been performed based on Nightingale Blood Biomarker Analysis platform. Proteomic profiling will be performed by both Scanning SWATH and OLINK® Explore 384 Oncology panel. History of H. pylori infection is examined by measuring serum IgG antibodies against H. pylori, using ELISA. Detailed lifestyle information collected by questionnaires includes education, smoking, snuff dipping, alcohol drinking, drug use, diet, and height/weight, etc. Metabolites will be log transformed prior to analyses, due to its usually skewed distribution. For each metabolite, firstly, CAG patients will be compared with all the CAG-free controls. Wilcoxon-Mann-Whitney test or Kruskal-Wallis test will be used for comparing differences of protein expressions between CAG and non-CAG groups, and multiple comparisons will be adjusted using Bonferroni correction. Generalized estimation equation (GEE) models with the robust option will be fitted to estimate the odds ratios (ORs). Second, in the comparison with MZ co-twin controls and DZ co-twin controls, only complete twin pairs with discordant CAG will be included in the study. Specifically, conditional logistic regression models will be used to control for the matching within co-twin pairs. The investigators will further combine metabolomics and proteomics data, and try to build up a CAG prediction model. Covariates will include age, sex, H. pylori seropositivity, education level, smoking, snuff dipping, and alcohol drinking. Joint effects of different metabolites and interaction with other covariates will also be examined.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12599

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm
      • Solna, Stockholm, Sweden, 17165
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population is part of the Swedish Twin Registry (STR), which collected questionnaire data from all twins born after 1886. The data in this specific study is a subset of the Screening Across the Lifespan (SALT) study within the STR, in which all twins born between 1911-1958 were interviewed between 1998-2002. The subcohort named TwinGene was set-up between the years 2004 and 2008 when participants were invited to respond to a questionnaire on common diseases and provide a blood sample.

Description

  1. Inclusion Criteria:

    • participants from the Screening Across the Lifespan (SALT) study within Swedish Twin Registry (STR) who responded to a questionnaire on common diseases and provide a blood sample;
    • both twins in the pair had to be alive and living in Sweden;
    • had been enrolled in other STR DNA sampling projects;

  2. Exclusion Criteria:

    • previously declined participation in future studies;
    • whose blood samples were unavailable or didn't pass initial lab-based QC;
    • whose samples were unable to link to the available environmental data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with chronic atrophic gastritis
Corpus-dominant chronic atrophic gastritis was characterized by a PGI/PGII ratio of less than 3.
Other: Metabolomic profiling
Metabolomic profiling using serum samples was performed based on Nightingale Blood Biomarker Analysis platform; Proteomic profiling will be performed by both Scanning SWATH and OLINK® Explore 384 Oncology panel.
Other Names:
  • Proteomic profiling
Healthy participants
Healthy participants in the TwinGene cohort were included.
Other: Metabolomic profiling
Metabolomic profiling using serum samples was performed based on Nightingale Blood Biomarker Analysis platform; Proteomic profiling will be performed by both Scanning SWATH and OLINK® Explore 384 Oncology panel.
Other Names:
  • Proteomic profiling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chronic atrophic gastritis
Time Frame: 1 Sep. 2020 to 31 Dec. 2021
Corpus-dominant chronic atrophic gastritis was characterized by a PGI/PGII ratio of less than 3.
1 Sep. 2020 to 31 Dec. 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-01939_VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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