Glucose Homeostasis and Shared Genetic Factors in Colorectal Cancer

NCT07648589 | Not Yet Recruiting DMC

• 2 other identifiers: ChangGungMH202600418A3202600418A3
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Cancer; Diabetes Mellitus; Glucose Homeostasis

Keywords

Colorectal Cancer; Diabetes Mellitus; Glucose Homeostasis; Hyperglycemia; SMAD7; Pleiotropic Genes; Cancer Genomics

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to Week 48

Secondary Outcomes (3)

• Expression level of SMAD7 in systemic blood and colorectal tissue

  Baseline to Week 48

• Concentrations of inflammatory and immunological biomarkers in systemic blood and colorectal tissue

  Baseline to Week 48

• Proportions of T cell subpopulations in systemic blood and colorectal tissue

  Baseline to Week 48

Study Arms (1)

Colorectal Cancer Cohort

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.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Retained biospecimens include peripheral blood samples and colorectal tissue specimens (fresh tissue and FFPE tissue when available). Samples may be used for DNA extraction, whole-exome sequencing, biomarker analyses, immune profiling, gene expression studies, immunohistochemistry, and future research related to colorectal cancer and glucose homeostasis.

MeSH Terms

Conditions

Colorectal Neoplasms; Diabetes Mellitus; Hyperglycemia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Yih Jong Chern, MD

CONTACT

+886-3-3281200 - 2101; ufo789.ufo789@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2029
• Last Updated: June 15, 2026

Record last verified: 2026-05