Impact of Environmental Factors and Metabolomics on Colorectal Cancer.

Active, not recruiting

• Conditions: Colorectal Cancer; Metabolic Disease

• Registration Number: NCT06643429
• Lead Sponsor: Dong Peng

Brief Summary

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.

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 Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival	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.	Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.

Trial Locations

Locations (1)

the First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China