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

NCT06267703 | Active Not Recruiting

• 1 other identifier: 2023-01939_VR
• Study Type: observational
• Target: 12,599
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Atrophic Gastritis

Keywords

Chronic Atrophic Gastritis; Stomach Cancer; Biomarker; Metabolome; Transcriptome; Proteome

Outcome Measures

Primary Outcomes (1)

• Chronic atrophic gastritis

  Corpus-dominant chronic atrophic gastritis was characterized by a PGI/PGII ratio of less than 3.

  1 Sep. 2020 to 31 Dec. 2021

Study Arms (2)

Participants with chronic atrophic gastritis

Corpus-dominant chronic atrophic gastritis was characterized by a PGI/PGII ratio of less than 3.

Other: Metabolomic profiling

Healthy participants

Healthy participants in the TwinGene cohort were included.

Other: Metabolomic profiling

Interventions

Metabolomic profiling OTHER

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.

Also known as: Proteomic profiling

Healthy participants; Participants with chronic atrophic gastritis

Eligibility Criteria

• Age: 46 Years - 97 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Solna, Stockholm County, 17165, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Participants from TwinGene provided blood samples.

MeSH Terms

Conditions

Gastritis, Atrophic; Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)