Impact of Environmental Factors and Metabolomics on Colorectal Cancer.

Impact of Environmental Factors and Metabolomics on Colorectal Cancer Development and Prognosis Based on Environmental Factors and Metabolomics.

Colorectal cancer is one of the malignant tumours with high morbidity and mortality worldwide, posing a serious threat to human health. In recent years, the incidence of colorectal cancer has been on the rise with changes in lifestyle and dietary habits. Although some progress has been made in treatments such as surgery, chemotherapy and radiotherapy, however, the early diagnosis, prognosis assessment and personalised treatment of colorectal cancer still face great challenges. Therefore, it is of great academic value and practical significance to deeply explore the influencing factors of colorectal cancer occurrence, development and its prognosis, especially the research on environmental factors and metabolomics.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Metabolic Disease
• Intervention / Treatment: Diagnostic test: colorectal cancer; Diagnostic test: colorectal neoplasm

Detailed Description

In this study, investigators collected clinical information, blood, urine and stool for ambient air pollution analysis, blood metabolomics analysis and stool macro-genetic sequencing by including patients from healthy control and colorectal cancer groups, respectively. Environmental factors, metabolomics and intestinal microbiota data were integrated and analysed to screen for indicators that play a key role in colorectal cancer development and construct a colorectal cancer prediction model.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All adult patients diagnosed with colorectal cancer and undergoing radical surgery for colorectal cancer at the study centre.

Description

Inclusion Criteria:

1. Healthy control group:

   • age ≥18 years old;
   • no history of malignant tumour;
   • willing to participate in this study and sign the informed consent form;
   • complete basic data.

2. Gastric cancer group:

   • age ≥18 years old;
   • patients diagnosed with gastric cancer by pathological biopsy before operation;
   • no chemotherapy, radiotherapy, targeted and immunotherapy before enrolment;
   • willing to participate in this study and sign the informed consent; complete clinical data.

Exclusion criteria:

• patients with primary malignant tumours other than gastric cancer;
• patients with serious cardiopulmonary insufficiency and other systemic diseases that affect the choice of treatment plan;
• patients who are not suitable for enrolment as assessed by the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the control group; Adults with no history of malignancy and willing to participate in this study.
the colorectal cancer group; Patients with preoperative diagnosis of colorectal cancer confirmed by pathological biopsy.	Diagnostic test: colorectal cancer; Patients diagnosed with colorectal cancer by pathological biopsy.
the colorectal adenoma group; Patients with preoperative diagnosis of colorectal adenoma confirmed by colonoscopy.	Diagnostic test: colorectal neoplasm; Patients diagnosed with colorectal adenoma confirmed by colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative complications	Surgical complications was defined as any postoperative complication occurring during the postoperative hospitalisation period.	From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.	From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months.

Collaborators and Investigators

• Sponsor: Dong Peng

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: colorectal cancer; metabolomics; air pollution; intestinal flora
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Metabolic Diseases
• Other Study ID Numbers: 2024-222-02

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