Colorectal CancerBRIDGE-CRCDMNCT07648589
Glucose Homeostasis and Shared Genetic Factors in Colorectal Cancer
An observational study of Colorectal Cancer and Diabetes Mellitus, run by Chang Gung Memorial Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Colorectal Cancer, Diabetes Mellitus, Glucose Homeostasis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 May 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Genetic and Molecular Insights Into Glucose Homeostasis and Colorectal Cancer: Exploring Pleiotropic Genes and Mechanistic Roles in Colorectal Cancer Patients
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.
Read more
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.
Read the 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.
- Conditions
- Colorectal Cancer, Diabetes Mellitus, Glucose Homeostasis
- Keywords
- Colorectal Cancer, Diabetes Mellitus, Glucose Homeostasis, Hyperglycemia, SMAD7, Pleiotropic Genes, Cancer Genomics
- Medical subject headings
- Colorectal Neoplasms, Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 48
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648589
- Sponsor's protocol ID
- ChangGungMH202600418A3
- Other IDs
- 202600418A3
- Acronym
- BRIDGE-CRCDM
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Molecular Insights Into Glucose Homeostasis and Colorectal Cancer: Exploring Pleiotropic Genes and Mechanistic Roles in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT07648589
- Acronym / sponsor ID
- BRIDGE-CRCDM / ChangGungMH202600418A3
- Conditions
- Colorectal Cancer, Diabetes Mellitus, Glucose Homeostasis
- Keywords
- Colorectal Cancer, Diabetes Mellitus, Glucose Homeostasis, Hyperglycemia, SMAD7, Pleiotropic Genes, Cancer Genomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between shared genetic variants and glucose homeostasis biomarkers
Time frame: Baseline to Week 48
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.
Incidence of colorectal cancer-related outcomes
Time frame: Baseline to Week 48
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Diabetes Mellitus, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yih Jong Chern, MD (+886-3-3281200 - 2101, ufo789.ufo789@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between shared genetic variants and glucose homeostasis biomarkers (time frame: Baseline to Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.