Impact of Environmental Factors and Metabolomics on Colorectal Cancer.

NCT ID: NCT06643429

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-10-01

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.

Conditions

Colorectal Cancer; Metabolic Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

the control group

Adults with no history of malignancy and willing to participate in this study.

No interventions assigned to this group

the colorectal cancer group

Patients with preoperative diagnosis of colorectal cancer confirmed by pathological biopsy.

colorectal cancer

Intervention Type: DIAGNOSTIC_TEST

Patients diagnosed with colorectal cancer by pathological biopsy.

the colorectal adenoma group

Patients with preoperative diagnosis of colorectal adenoma confirmed by colonoscopy.

colorectal neoplasm

Intervention Type: DIAGNOSTIC_TEST

Patients diagnosed with colorectal adenoma confirmed by colonoscopy.

Interventions

colorectal cancer

Patients diagnosed with colorectal cancer by pathological biopsy.

Intervention Type: DIAGNOSTIC_TEST

colorectal neoplasm

Patients diagnosed with colorectal adenoma confirmed by colonoscopy.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong Peng

OTHER

Sponsor Role: lead

Responsible Party

Dong Peng

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

2024-222-02

Identifier Type: -

Identifier Source: org_study_id