- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06886022
Diagnosis, Treatment, and Prevention of Colorectal Cancer Amid Abnormal Lipid Metabolism
The Establishment of a Diagnosis, Treatment, and Prevention System for Colorectal Cancer Under the Background of Abnormal Lipid Metabolism in Digitalization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer (CRC) is one of the most common gastrointestinal malignancies worldwide, accounting for approximately 8% of all cancer cases [1]. Numerous epidemiological studies have identified obesity as a risk factor for CRC [2]. Abnormal fat distribution and lipid metabolism dysregulation contribute to a chronic, low-grade inflammatory state and increased oxidative stress, potentially triggering mutations, carcinogenesis, and tumor cell proliferation [3]. Research suggests that adipose tissue and its associated inflammatory factors may play a key role in the obesity-cancer link.
Regarding fat distribution, visceral adipose tissue exhibits higher metabolic activity compared to subcutaneous fat [4]. Excess visceral fat promotes insulin resistance and inflammatory pathways [5], potentially increasing CRC risk. Abnormal visceral fat distribution is also associated with postoperative complications, survival time, and the efficacy of adjuvant therapy in CRC patients [6]. Furthermore, non-alcoholic fatty liver disease (NAFLD), potentially representing a specific type or hepatic manifestation of abnormal fat distribution, is considered a risk factor for CRC.
Our research group previously conducted a retrospective study involving 93 patients undergoing gastrointestinal surgery (including CRC). We found that, compared to the group without perioperative weight loss, patients experiencing perioperative weight loss exhibited decreased serum albumin, elevated blood glucose, and elevated serum cholesterol. Multivariate regression analysis indicated that serum cholesterol was a risk factor for perioperative weight loss, showing a positive correlation.
Currently, we are conducting a small-scale study specifically focusing on CRC patients. By collecting perioperative data, including body composition, fat distribution, BMI, abdominal CT scans, inflammatory markers, and obesity-related indices, we aim to elucidate the roles of lipid metabolism, fat distribution, and related inflammatory factors in the development and progression of CRC, as well as their impact on perioperative adverse clinical outcomes. We have obtained promising preliminary results, establishing a foundation for digitizing our overall research findings.
This project aims to establish a research system correlating lipid metabolism, inflammation, and CRC. A CRC patient lipid metabolism database will serve as a platform to expand our previous study's sample size. By integrating and analyzing data from this platform, we will develop a digital, visualized "three-tier prevention" network for CRC, integrating a "digital vaccine" (predictive screening model), "digital drug" (intervention model targeting associated pathogenic mechanisms), and "digital rehabilitation" (preventive system combining early warning and treatment).
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 20-80 years, confirmed CRC diagnosis, consent to participate in the study.
Exclusion Criteria:
- Age <20 or >80 years; inability to perform activities of daily living; presence of infectious diseases; lack of communication and cognitive abilities; refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observation
Colorectal cancer patients after surgery
|
Procedures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abdominal CT L3 level adipose tissue surface
Time Frame: Preoperatively
|
Abdominal CT L3 level adipose tissue surface
|
Preoperatively
|
|
Abdominal CT L3 level skeletal muscle surface
Time Frame: Preoperatively
|
Preoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival
Time Frame: 3 years
|
3 years
|
|
Progression Free Survival
Time Frame: 3 years
|
3 years
|
|
Disease Free Survival
Time Frame: 3 years
|
3 years
|
|
Tumor TNM stage
Time Frame: immediately after the procedure
|
immediately after the procedure
|
|
Hand grip strength
Time Frame: Preoperatively; Postoperatively Day 1,3,5,7
|
Preoperatively; Postoperatively Day 1,3,5,7
|
|
Waist Circumference
Time Frame: Preoperatively
|
Preoperatively
|
|
Calf Circumference
Time Frame: Preoperatively; Postoperatively Day 1 3 5 7
|
Preoperatively; Postoperatively Day 1 3 5 7
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jing Xu, PhD, Tianjin Union Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023C03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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