Glucose Homeostasis and Shared Genetic Factors in Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Diabetes Mellitus, Glucose Homeostasis. Basic parameters: 20 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Genetic and Molecular Insights Into Glucose Homeostasis and Colorectal Cancer: Exploring Pleiotropic Genes and Mechanistic Roles in Colorectal Cancer Patients
Overview
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.
Detailed description
Colorectal cancer (CRC) and diabetes mellitus (DM) are major public health challenges worldwide. Epidemiological studies have demonstrated a bidirectional association between these two diseases, suggesting the existence of shared biological mechanisms involving glucose regulation, inflammation, immunity, and genetic susceptibility. However, the genetic and molecular pathways linking CRC and abnormal glucose homeostasis remain incompletely understood.
Recent genomic studies have identified several candidate pleiotropic genes that may influence both glycemic traits and CRC risk. Among these candidates, SMAD7 has emerged as a potential shared genetic factor involved in glucose homeostasis, inflammatory signaling, immune regulation, and colorectal tumorigenesis. SMAD7 participates in the TGF-β and NF-κB signaling pathways and may influence interactions between metabolic dysregulation, chronic inflammation, and cancer progression.
The present study is designed to investigate the genetic, molecular, metabolic, and immunological relationships between CRC and glucose homeostasis abnormalities. Large-scale genomic resources and clinical data will be integrated to identify and validate shared genetic variants associated with both conditions. In addition, a prospective observational cohort will be established to evaluate longitudinal changes in glucose metabolism, inflammatory biomarkers, immune cell profiles, and gene expression patterns in patients with CRC.
Particular emphasis will be placed on the characterization of systemic and tumor-associated immune responses, including cytotoxic T lymphocytes and regulatory T cells, and their relationships with glucose homeostasis and candidate genetic variants. Blood samples and available colorectal tissue specimens will be analyzed using molecular, genomic, and immunologic approaches to explore potential mechanisms linking metabolic abnormalities and colorectal cancer progression.
By integrating genetic discovery with clinical and biological investigations, this study aims to improve understanding of the shared pathways between CRC and diabetes-related traits, identify biomarkers associated with disease progression, and provide a foundation for future precision medicine strategies in colorectal cancer.
Primary outcome measures
- Association between shared genetic variants and glucose homeostasis biomarkers [Time frame: Baseline to Week 48]
- Incidence of colorectal cancer-related outcomes [Time frame: Baseline to Week 48]
Secondary outcome measures (3)
- Expression level of SMAD7 in systemic blood and colorectal tissue [Time frame: Baseline to Week 48]
- Concentrations of inflammatory and immunological biomarkers in systemic blood and colorectal tissue [Time frame: Baseline to Week 48]
- Proportions of T cell subpopulations in systemic blood and colorectal tissue [Time frame: Baseline to Week 48]
Eligibility criteria
Inclusion criteria
- Age 20 to 85 years
- Histologically confirmed colorectal cancer
- Newly diagnosed colorectal cancer at the time of enrollment
- No prior diagnosis of diabetes mellitus
- Ability to provide written informed consent
Exclusion criteria
- 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
- Inability or unwillingness to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07648589 · ChangGungMH202600418A3 · 202600418A3