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NCT Number: NCT06886022

Diagnosis, Treatment, and Prevention of Colorectal Cancer Amid Abnormal Lipid Metabolism

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colorectal cancer procedures

Procedure

Procedures

Primary outcomes

  1. Abdominal CT L3 level adipose tissue surface

    Time frame: Preoperatively

    Abdominal CT L3 level adipose tissue surface

  2. Abdominal CT L3 level skeletal muscle surface

    Time frame: Preoperatively

Secondary outcomes

  1. Tumor TNM stage

    Time frame: immediately after the procedure

  2. Overall Survival

    Time frame: 3 years

  3. Disease Free Survival

    Time frame: 3 years

  4. Hand grip strength

    Time frame: Preoperatively; Postoperatively Day 1,3,5,7

  5. Waist Circumference

    Time frame: Preoperatively

  6. Calf Circumference

    Time frame: Preoperatively; Postoperatively Day 1 3 5 7

  7. Progression Free Survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Tianjin Union Medical Center

Other

Registry information

Official study title

The Establishment of a Diagnosis, Treatment, and Prevention System for Colorectal Cancer Under the Background of Abnormal Lipid Metabolism in Digitalization

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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