Colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for the colorectal cancer group: 1. Aged between 40 and 75 years; 2. Diagnosed with colorectal cancer either pathologically or clinically; 3. Sufficient clinical information, including pathology reports and imaging findings; 4. Able to understand the guidance and cooperate to complete the metabolomics sampling; 5. Consent to sign the informed consent form. Inclusion criteria for advanced adenoma group: 1. Age between 40-75 years; 2. Pathologically confirmed diagnosis of advanced adenoma, meeting one or more of the following criteria: Long diameter =10 mm; Villous or tubulovillous adenoma; High-grade dysplasia; 3. Able to understand instructions and cooperate with comprehensive metabolomics sampling; 4. Agree to sign informed consent. Inclusion criteria for the control group: 1. Age between 40 and 75 years; 2. Able to understand and cooperate with comprehensive metabolomics sampling; 3. Agree to sign an informed consent form; 4. Completed a colonoscopy within the last three months, and has a report of the examination results. Among these, those meeting any one or more of the following criteria will be classified as a high-risk subgroup: (1)First-degree relatives with a history of colorectal cancer (CRC); (2)Personal history of cancer (any malignant tumor); (3) Personal history of intestinal polyps; (4)Additionally having two or more of the following: Chronic constipation (constipation lasting more than 2 months each year over the last 2 years); Chronic diarrhea (cumulative diarrhea lasting more than 3 months in the last 2 years, with each episode lasting over 1 week); Mucous or bloody stools; History of adverse life events (occurring within the last 20 years and causing significant psychological trauma or distress after the event); History of chronic appendicitis or appendectomy; History of chronic biliary disease or cholecystectomy. Those meeting all the following criteria will be classified as a general risk subgroup: No history of adenomas or sessile serrated polyps; No long-term unresolved (8-10 years) inflammatory bowel disease history; No family history of colorectal cancer (first-degree relatives); Does not meet the enrollment criteria for the 'high-risk subgroup'.
Exclusion criteria
Exclusion criteria: Exclusion criteria for colorectal cancer group: 1.Previously received any treatment for colorectal cancer, including chemotherapy, radiotherapy, targeted therapy, etc.; 2.Coexisting other malignant tumors, unless it is a skin basal cell carcinoma or squamous cell carcinoma that has been cured for over 5 years; 3.Patients with severe complications (such as infection, bleeding, heart and lung failure, etc.) and those with chronic diseases that affect immune function or metabolism, such as AIDS, autoimmune diseases, poorly controlled diabetes, etc.; 4.History of mental illness, drug abuse, or drug dependence; 5.Surgical procedures performed within the last 7 days; 6.Blood donation or significant bleeding (>450mL) within the last 7 days, or receiving blood transfusions or blood products; 7.Emergency cases or requiring resuscitation; 8.Subjects who have received organ transplantation or previously underwent non-autologous (allogeneic) bone marrow or stem cell transplantation; 9.Pregnant women with positive pregnancy tests or lactating women; 10.Various reasons that prevent adequate metabolomics sampling; 11.The patient or their direct relatives do not agree to sign the informed consent form; l. Other reasons determined by the researcher that make the subject unsuitable for inclusion. Exclusion criteria for advanced adenoma group: 1.Inability to complete metabolomics sampling due to various reasons; 2.The patient or their immediate family members do not agree to sign the informed consent form; 3.Previously received any treatment for colorectal cancer, including chemotherapy, radiotherapy, targeted therapy, etc.; 4.Patients with serious complications (such as infection, bleeding, pulmonary heart failure, etc.) and those with chronic diseases affecting immune function or metabolism, such as AIDS, autoimmune diseases, poorly controlled diabetes, etc.; 5.History of malignant tumors, unless it is skin basal cell carcinoma or squamous cell carcinoma that has been cured for more than 5 years; 6.History of mental illness, drug abuse, or drug dependence; 7.Blood donation or significant bleeding (>450mL) within the last 7 days, or those who have received blood transfusions or used blood products; 8.Subjects who have received organ transplants or previously received non-autologous (allogeneic) bone marrow or stem cell transplants; 9.Pregnancy or lactation; 10.Emergency or requiring resuscitation; 11.Other reasons deemed by the investigator as unsuitable for inclusion. Exclusion criteria for the control group: 1.Presence of colorectal cancer or advanced adenomas confirmed by colonoscopy; 2.Incomplete metabolomics sampling due to various reasons; 3.The patient and direct relatives do not agree to sign the informed consent form; 4.History of mental illness, substance abuse, or drug dependence; 5.Pregnant or breastfeeding; 6.Emergency situation or requiring resuscitation; 7.Blood donation or significant blood loss (>450mL) within the last 3 months, or receiving a blood transfusion or using blood products; 8.Subjects who have undergone organ transplantation or have previously received non-autologous (allogeneic) bone marrow or stem cell transplantation; 9.Other reasons deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Area under Curve , AUC; | — |
Countries
China
Contacts
The Eighth Hospital of Wuhan