Impact of Environmental Factors and Metabolomics on Colorectal Cancer.

NCT06643429 — Active not recruiting, 700 participants, Dong Peng

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

Registry	NCT06643429
Status	Active not recruiting
Study type	Observational
Enrollment	700 (Estimated)
Sponsor	Dong Peng (Other)
Conditions	Colorectal Cancer, Metabolic Disease
Interventions	colorectal cancer, colorectal neoplasm (Diagnostic test)
Dates	start 2024-10-01, primary completion 2025-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2024-10-16, last updated 2024-10-16
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Interventions	Description
the control group		Adults with no history of malignancy and willing to participate in this study.
the colorectal cancer group	Diagnostic Test: colorectal cancer	Patients with preoperative diagnosis of colorectal cancer confirmed by pathological biopsy.
the colorectal adenoma group	Diagnostic Test: colorectal neoplasm	Patients with preoperative diagnosis of colorectal adenoma confirmed by colonoscopy.

colorectal cancer (Diagnostic test): Patients diagnosed with colorectal cancer by pathological biopsy.
colorectal neoplasm (Diagnostic test): Patients diagnosed with colorectal adenoma confirmed by colonoscopy.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
the First Affiliated Hospital of Chongqing Medical University	Chongqing, Chongqing Municipality	China

My Notes

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