NCT07035262

Brief Summary

The aim of this study is to systematically analyze the dynamic pattern of preoperative and postoperative serum metabolites in colorectal cancer patients through metabolomics technology, and to screen the key metabolites with statistical differences and explore their correlation with surgical interventions by combining the baseline characteristics of the patients with the perioperative clinical data; to further reveal the impact of surgery on the body's metabolic remodeling pattern, and to explore the potential biomarkers and regulatory pathways, providing a theoretical basis for elucidating the metabolic mechanism. Investigaters will further reveal the impact of surgery on metabolic remodeling, explore potential biomarkers and regulatory pathways, provide theoretical basis for elucidating the metabolic mechanism, and evaluate its clinical translational value (e.g., postoperative monitoring, targeted intervention, etc.), so as to lay the foundation for the subsequent basic research and precise treatment strategies.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

June 16, 2025

Last Update Submit

June 16, 2025

Conditions

Keywords

colorectal cancerpostoperative complicationsurgerymetabolites

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    Postoperative complications occurring within two months after surgery.

    From the first day of surgery to two months after surgery

Study Arms (1)

the colorectal cancer group

patients diagnosed with colorectal cancer

Other: serum metabolites

Interventions

serum metabolites before and after colorectal cancer surgery

the colorectal cancer group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with colorectal cancer

You may qualify if:

  • Previous consent to participate;
  • Blood drawn and serum samples extracted and preserved both preoperatively and postoperatively;
  • Successful detection of metabolomics profiles from serum samples;
  • Acceptance of a standard radical colorectal cancer procedure;
  • Complete perioperative data available;
  • Adults with a pathologic diagnosis of colorectal cancer

You may not qualify if:

  • Have or have had a previous history of other malignancies;
  • Have a history of radiotherapy treatment;
  • Have a history of inflammatory bowel disease;
  • Have a familial history of genetic disorders;
  • Missing baseline data (age, BMI, gender, previous medical history, etc.);
  • Failed to leave the hospital earlier than medically indicated;
  • Failed to sign an informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2025

First Posted

June 25, 2025

Study Start

January 1, 2023

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Ethics committees require no data sharing due to patient privacy protection.

Locations