To hear about similar clinical trials, please enter your email below
Trial Title:
Multi-omics Analyses on Etiology and Early Detection of Stomach Cancer Precursor Lesions
NCT ID:
NCT06267703
Condition:
Chronic Atrophic Gastritis
Conditions: Official terms:
Stomach Neoplasms
Gastritis
Gastritis, Atrophic
Atrophy
Conditions: Keywords:
Chronic Atrophic Gastritis
Stomach Cancer
Biomarker
Metabolome
Transcriptome
Proteome
Study type:
Observational [Patient Registry]
Overall status:
Active, not recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Metabolomic profiling
Description:
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.
Arm group label:
Healthy participants
Arm group label:
Participants with chronic atrophic gastritis
Other name:
Proteomic profiling
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
46 Years
Maximum age:
97 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Karolinska Institutet
Address:
City:
Solna
Zip:
17165
Country:
Sweden
Start date:
January 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Karolinska Institutet
Agency class:
Other
Source:
Karolinska Institutet
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06267703
