Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Metabolic Marker, Prognosis, Early Diagnosis
Brief summary
This prospective clinical observational study aims to construct a metabolite database specifically for colorectal cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in colorectal cancer, thereby a establishing safe, convenient, and highly sensitive method for early screening and prognostic prediction.
Interventions
None listed
Sponsors
Shanghai Minimally Invasive Surgery Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \*\*Healthy Controls:\*\* 1. Age ≥ 18 years; 2. Signed informed consent and willingness to participate in the project. \*\*Colorectal Cancer:\*\* 1. Age ≥ 18 years; 2. Performance status (ECOG) score ≤ 1; 3. Histopathologically confirmed colorectal adenocarcinoma; 4. No family history of hereditary cancer; 5. No prior anti-tumor treatment; 6. Availability of primary tumor tissue from surgery or biopsy that meets submission requirements; 7. Availability of peripheral blood samples that meet submission requirements; 8. Willingness and ability to sign the informed consent form to participate in the study.
Exclusion criteria
* \*\*Healthy Controls:\*\* 1. Individuals at high risk for hereditary colorectal adenocarcinoma, including family members of the following diseases: family history of gastrointestinal tumors, familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC/LS), and Peutz-Jeghers syndrome (P-J syndrome); 2. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease; 3. Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured; 4. History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month; 5. Regular use of immunosuppressive drugs within the past 6 months; 6. Long-term use of other medications that may affect metabolism, such as hormones; 7. Inability or unwillingness to cooperate with follow-up visits and related examinations; 8. Inability to eat normally or requiring medications or enemas for bowel movements; 9. Presence of psychiatric disorders or other severe cardiovascular diseases; 10. Pregnant, breastfeeding, or planning to become pregnant within the next year; 11. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision. \*\*Colorectal Cancer:\*\* 1. A clear family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, etc.; 2. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision; 3. Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured; 4. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease; 5. Presence of poorly controlled chronic comorbidities that may affect prognosis; 6. Presence of psychiatric disorders or other severe cardiovascular diseases; 7. Pregnant, breastfeeding, or planning to become pregnant within the next year; 8. Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.; 9. Any severe and/or uncontrolled medical conditions, as judged by the investigator, that may affect the patient's ability to participate in the study or interfere with study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | The time from the start of treatment to death due to any cause. |
| Disease-Free Survival | 3 years | Disease-Free Survival (DFS) refers to the length of time after primary treatment for a disease during which the patient remains free of certain signs or symptoms of the disease. It is typically measured from the start of treatment until the first recurrence or relapse of the disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative Predictive Value | 3 years | The Negative Predictive Value (NPV) indicates how likely it is that a person does not have the disease if the test result is negative. |
| Assessment of Important Metabolic Biomarkers | 3 years | — |
| Hazard Ratio | 3 years | The hazard ratio is a measure of the relative risk of an event occurring in one group compared to another group. It is used to quantify the difference in the rate at which events occur between two groups, typically a treatment group and a control group. |
| Cancer-Related Mortality | 3 years | — |
| Time to Recurrence and Metastasis and Specific Sites | 3 years | — |
| Recurrence and Metastasis Rate | 3 years | — |
| Positive Predictive Value | 3 years | The Positive Predictive Value (PPV) indicates how likely it is that a person actually has the disease if the test result is positive. |
Countries
China
Contacts
Primary ContactJing Sun
Outcome results
None listed