Clinical trial NCT06886022: Diagnosis, Treatment, and Prevention of Colorectal Cancer Amid Abnormal Lipid Metabolism
Official title: The Establishment of a Diagnosis, Treatment, and Prevention System for Colorectal Cancer Under the Background of Abnormal Lipid Metabolism in Digitalization
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Lipid Metabolism
Lead sponsor: Tianjin Union Medical Center
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age 20-80 years, confirmed CRC diagnosis

Brief summary: This research project investigates the interplay between lipid metabolism, inflammation, and colorectal cancer (CRC). We are building a comprehensive database of CRC patients, incorporating clinical data, body composition measurements, imaging findings, and biomarkers related to lipid metabolism and inflammation. Our goal is to identify how these factors contribute to CRC development, progression, and perioperative outcomes. Ultimately, we aim to develop a digital, personalized "three-tier prevention" strategy encompassing early risk prediction, targeted interventions, and comprehensive rehabilitation for improved CRC patient care.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Abdominal CT L3 level adipose tissue surface
timeFrame: Preoperatively
measure: Abdominal CT L3 level skeletal muscle surface
timeFrame: Preoperatively
Secondary outcomes:
measure: Tumor TNM stage
timeFrame: immediately after the procedure
measure: Overall Survival
timeFrame: 3 years
measure: Disease Free Survival
timeFrame: 3 years
measure: Hand grip strength
timeFrame: Preoperatively; Postoperatively Day 1,3,5,7
measure: Waist Circumference
timeFrame: Preoperatively
measure: Calf Circumference
timeFrame: Preoperatively; Postoperatively Day 1 3 5 7
measure: Progression Free Survival
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Union Medical Center
name: Jing Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References: