Impact of Environmental Factors and Metabolomics on Colorectal Cancer.

NCT06643429 | Active Not Recruiting DMC

• 1 other identifier: 2024-222-02
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Metabolic Disease

Keywords

colorectal cancer; air pollution; metabolomics; intestinal flora

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

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

the colorectal adenoma group

Patients with preoperative diagnosis of colorectal adenoma confirmed by colonoscopy.

Diagnostic Test: colorectal neoplasm

Interventions

colorectal cancer DIAGNOSTIC_TEST

Patients diagnosed with colorectal cancer by pathological biopsy.

the colorectal cancer group

colorectal neoplasm DIAGNOSTIC_TEST

Patients diagnosed with colorectal adenoma confirmed by colonoscopy.

the colorectal adenoma group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong Peng: lead

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Metabolic Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)