Colorectal CancerNCT06886022
Diagnosis, Treatment, and Prevention of Colorectal Cancer Amid Abnormal Lipid Metabolism
An observational study of Colorectal Cancer, run by Tianjin Union Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colorectal cancer procedures
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age 20-80 years, confirmed CRC diagnosis
Who may be able to join
- Age 20-80 years, confirmed CRC diagnosis, consent to participate in the study.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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).
- Conditions
- Colorectal Cancer
- Being tested
- Colorectal cancer procedures
- Keywords
- Colorectal Cancer, Lipid Metabolism
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal cancer proceduresProcedure or surgery
Procedures
| Study group | Role | What they receive |
|---|---|---|
| Observation | Colorectal cancer patients after surgery Receives: Procedure: Colorectal cancer procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal CT L3 level adipose tissue surface
Abdominal CT L3 level adipose tissue surface
Measured: Preoperatively
Abdominal CT L3 level skeletal muscle surface
Measured: Preoperatively
Secondary outcomes (7)
Tumor TNM stage
Measured: immediately after the procedure
Overall Survival
Measured: 3 years
Disease Free Survival
Measured: 3 years
Hand grip strength
Measured: Preoperatively; Postoperatively Day 1,3,5,7
Waist Circumference
Measured: Preoperatively
Calf Circumference
Measured: Preoperatively; Postoperatively Day 1 3 5 7
Progression Free Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Jan 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tianjin Union Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Xu, Tianjin Union Medical Center
- Investigators
- Jing Xu, PhD, Principal investigator, Tianjin Union Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886022
- Sponsor's protocol ID
- 2023C03
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of a Diagnosis, Treatment, and Prevention System for Colorectal Cancer Under the Background of Abnormal Lipid Metabolism in Digitalization
- ClinicalTrials.gov ID
- NCT06886022
- Acronym / sponsor ID
- 2023C03
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Lipid Metabolism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tianjin Union Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Procedure: Colorectal cancer proceduresColorectal cancer patients after surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age 20-80 years, confirmed CRC diagnosis
Key inclusion criteria (1 listed)
- Age 20-80 years, confirmed CRC diagnosis, consent to participate in the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal cancer proceduresProcedures | Procedure or surgery | Observation |
Primary outcome
Abdominal CT L3 level adipose tissue surface
Time frame: Preoperatively
Abdominal CT L3 level adipose tissue surface
Abdominal CT L3 level skeletal muscle surface
Time frame: Preoperatively
7 secondary outcomes
Tumor TNM stage
Time frame: immediately after the procedure
Overall Survival
Time frame: 3 years
Disease Free Survival
Time frame: 3 years
Hand grip strength
Time frame: Preoperatively; Postoperatively Day 1,3,5,7
Waist Circumference
Time frame: Preoperatively
Calf Circumference
Time frame: Preoperatively; Postoperatively Day 1 3 5 7
Progression Free Survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Xu, PhD principal investigator
Tianjin Union Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Tianjin Union Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal CT L3 level adipose tissue surface (time frame: Preoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.