Glucose Homeostasis and Shared Genetic Factors in Colorectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-85
SponsorChang Gung Memorial Hospital
About this trial
Colorectal cancer (CRC) and diabetes mellitus are two common diseases that frequently occur together and may share underlying genetic, metabolic, and immune-related mechanisms. Previous studies have shown that diabetes is associated with an increased risk of colorectal cancer and poorer clinical outcomes, while colorectal cancer itself may also influence glucose metabolism.
This prospective observational study aims to investigate the relationships among glucose homeostasis, shared genetic factors, inflammatory responses, immune cell profiles, and colorectal cancer outcomes. Participants with colorectal cancer and non-colorectal cancer controls will undergo serial assessments of glucose-related biomarkers, inflammatory markers, immune cell populations, and genetic analyses over time.
The study will focus on identifying shared genetic variants that may contribute to both colorectal cancer and diabetes-related traits, as well as exploring biological pathways involving inflammation, immune regulation, and metabolism. Blood samples and available colorectal tissue specimens will be analyzed to evaluate gene expression, immune cell distribution, and molecular changes associated with disease progression.
The results of this study may improve understanding of the biological links between colorectal cancer and diabetes, facilitate the development of personalized risk assessment strategies, and identify potential biomarkers and therapeutic targets for patients with colorectal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 20 to 85 years
Histologically confirmed colorectal cancer
Newly diagnosed colorectal cancer at the time of enrollment
No prior diagnosis of diabetes mellitus
Disqualifiers
Age younger than 20 years or older than 85 years
Pre-existing diagnosis of diabetes mellitus
Severe obesity (body mass index ≥35 kg/m²)
Pregnancy
Trial population
The study population consists of adult patients aged 20 to 85 years with newly diagnosed colorectal cancer treated at Chang Gung Memorial Hospital. Participants without pre-existing diabetes mellitus will be enrolled and followed prospectively. Clinical data, blood samples, and available colorectal tissue specimens will be collected for analyses of glucose homeostasis, shared genetic variants, inflammatory biomarkers, and immune cell profiles.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Colorectal Cancer Cohort
Trial outcomes
Primary outcomes
1
Association between shared genetic variants and glucose homeostasis biomarkers
Concentrations of fasting plasma glucose (mg/dL), hemoglobin A1c (%), fasting insulin (μIU/mL), and C-peptide (ng/mL) will be measured at baseline and during follow-up. Associations between identified shared genetic variants (e.g., SMAD7) and glucose homeostasis biomarkers will be assessed using regression analyses.
Time frame
Baseline to Week 482
Incidence of colorectal cancer-related outcomes
Occurrence of colorectal cancer-related outcomes, including recurrence, progression, or mortality, during the follow-up period. Event rates (%) and time-to-event outcomes will be recorded and analyzed according to genetic variant status.
Time frame
Baseline to Week 48Secondary outcomes
1
Expression level of SMAD7 in systemic blood and colorectal tissue
SMAD7 expression levels will be measured in systemic blood and local colorectal tissue samples using quantitative polymerase chain reaction (qPCR) or RNA sequencing. Expression levels will be reported as relative expression values, normalized gene expression counts, or fold change across predefined exposure groups.
Time frame
Baseline to Week 482
Concentrations of inflammatory and immunological biomarkers in systemic blood and colorectal tissue
Inflammatory and immunological biomarkers will be measured in systemic blood and local colorectal tissue samples using enzyme-linked immunosorbent assay, multiplex cytokine assay, immunohistochemistry, flow cytometry, or transcriptomic profiling, as applicable. Outcomes will include biomarker concentrations, staining scores, immune cell proportions, or normalized expression values across predefined exposure groups.
Time frame
Baseline to Week 483
Proportions of T cell subpopulations in systemic blood and colorectal tissue
T cell subpopulations, including cytotoxic T cells, regulatory T cells, helper T cells, and other relevant T cell subsets, will be measured in systemic blood and local colorectal tissue samples using flow cytometry, immunohistochemistry, or single-cell RNA sequencing, as applicable. Outcomes will be reported as percentages of total lymphocytes, percentages of CD3+ T cells, cell counts, staining scores, or normalized cell abundance estimates.
Time frame
Baseline to Week 48Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: