Study on the characteristics of cold and heat syndrome of colorectal cancer based on intestinal microecology and the precision of intervention scheme for dominant populatio

Not Applicable

• Conditions: colorectal cancer

• Registration Number: ITMCTR2023000043
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with new-onset colonic adenoma:
(1) Patients with colonic adenoma diagnosed by colonoscopy within 14 days; (2) Age = 18 years, gender is not limited; (3) Good compliance, signed informed consent.
Patients with early and mid-stage colorectal cancer before surgery:
(1) There is a clear pathological diagnosis of colorectal cancer, stage I-III and no radical surgery; (2) Patients who have not undergone radiotherapy and chemotherapy; (3) Age = 18 years old, gender is not limited; (4) Good compliance, signed informed consent.
Chemotherapy ± targeted/immunized colorectal cancer patients:
(1) Patients with a clear pathological diagnosis of colorectal cancer who are about to or are receiving 5-fu-based double- or triple-drug chemotherapy or combined targeted or immunotherapy; (2) aged = 18 years, gender (3) The expected survival time is more than 3 months; (4) The compliance is good, and the informed consent is signed.
Patients with advanced colorectal cancer:
(1) Patients with advanced tumors who have a clear pathological diagnosis of colorectal cancer and have not received Western medicine treatment in the past 1 month; (2) Age = 18 years old, gender is not limited; (3) Expected survival time is greater than 3 months; (4) ) had good compliance and signed an informed consent form.

Exclusion Criteria

(1) Patients with cognitive impairment, or patients with brain metastases who have clinical symptoms and cannot answer the questionnaire; (2) Patients with severe infection, severe heart, liver, kidney, and insufficiency; (3) Patients with malignant tumors Patients with colon adenoma and colorectal cancer patients with other uncured malignant tumors; (4) The patients are in the infection period (virus, bacteria, fungi and other microbial infections), or other disease stages that may affect the judgment of cold and heat syndrome in the short term ; (5) Other conditions that the researchers think are not suitable for inclusion.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis and curative effect evaluation scale of cold and heat syndrome in colorectal cancer;

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy-Colorectal(FACT-C);Karnofsky score;Edmonton symptom assessment scale;TCM Kidney Deficiency Scale;Information collection of the four diagnosis of traditional Chinese medicine;TCM Spleen Deficiency Scale;TCM Syndrome Diagnostic Scale;