An observational study in Colorectal Cancer, Diabetes Mellitus and Glucose Homeostasis, sponsored by Chang Gung Memorial Hospital. Not yet recruiting. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Chang Gung Memorial Hospital · Observational
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.
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 200 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with newly diagnosed colorectal cancer without pre-existing diabetes mellitus at enrollment. Participants will be prospectively followed for 48 weeks to evaluate the development of diabetes mellitus and changes in glucose homeostasis. Serial assessments will include fasting glucose, HbA1c, insulin, C-peptide, inflammatory biomarkers, immune cell profiles, and genetic analyses. Blood samples and available colorectal tissue specimens will be collected for the evaluation of shared genetic variants, SMAD7-related pathways, and molecular mechanisms linking glucose dysregulation and colorectal cancer.
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 48
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 48
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 48
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 48
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 48
No study locations are listed for this record.
Plan to share: Undecided — The decision regarding sharing of individual participant data has not yet been determined. Future data sharing will be considered in accordance with institutional policies, ethical approvals, participant consent, and applicable privacy regulations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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