Clinical trial NCT06643429: Impact of Environmental Factors and Metabolomics on Colorectal Cancer.
Official title: Impact of Environmental Factors and Metabolomics on Colorectal Cancer Development and Prognosis Based on Environmental Factors and Metabolomics.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Metabolic Disease
Keywords: colorectal cancer
air pollution
metabolomics
intestinal flora
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of postoperative complications
timeFrame: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Secondary outcomes:
measure: Overall survival
timeFrame: 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.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: