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Active, Not Recruiting

NCT Number: NCT06643429

Impact of Environmental Factors and Metabolomics on Colorectal Cancer.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metabolic Disease Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

colorectal cancer

Diagnostic Test

Patients diagnosed with colorectal cancer by pathological biopsy.

colorectal neoplasm

Diagnostic Test

Patients diagnosed with colorectal adenoma confirmed by colonoscopy.

Primary outcomes

  1. Rate of postoperative complications

    Time frame: 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

  1. Overall survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dong Peng

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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