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

March 19, 2025 updated by: Jing Xu, Tianjin Union Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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

Observational

Enrollment (Estimated)

1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Age 20-80 years, confirmed CRC diagnosis

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jing Xu, PhD, Tianjin Union Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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