Microplastics in Paraneoplastic and Intratumoral for Colorectal Cancer

NCT07063550 | Active Not Recruiting DMC

• 1 other identifier: 2024-531-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to identify and characterize microplastics present in peritumoral and intratumoral tissues of colorectal cancer patients, and to investigate their associations with gut microbiome composition and metabolic profiles. By integrating microplastic analysis with metagenomic and metabolomic data, we aim to explore the potential impact of environmental microplastic exposure on tumor microenvironment alterations, microbial dysbiosis, and metabolic reprogramming in colorectal cancer.

Conditions

Colorectal Cancer (MSI-H); Microplastic Exposure

Keywords

colorectal cancer; microplastic; Paraneoplastic; Genomics; Metabolomics

Outcome Measures

Primary Outcomes (1)

• genomics

  Genomics was tested by preoperative blood specimens.

  Blood specimens were obtained within one week prior to surgery.

Secondary Outcomes (1)

• metabolomics

  Blood specimens were obtained within one week prior to surgery.

Study Arms (1)

the colorectal cancer group

patients diagnosed with colorectal cancer

Other: exposure to microplastic

Interventions

exposure to microplastic OTHER

Microplastic content in cancerous and paracancerous tissues

the colorectal cancer group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with colorectal cancer and received rectal cancer surgery

You may qualify if:

• Adult patients (≥18 years old) with histologically confirmed colorectal adenocarcinoma.
• Undergoing elective radical colorectal cancer resection at the study hospital.
• No prior chemotherapy, radiotherapy, or targeted therapy before surgery.
• Availability of both tumor tissue and adjacent normal (peritumoral) tissue samples during surgery.
• Willingness to provide stool and/or blood samples for metagenomic and metabolomic analysis.
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

• Patients with a history of other malignancies within the past 5 years.
• Emergency surgery due to obstruction, perforation, or bleeding.
• Inadequate sample quality or volume for microplastic, metagenomic, or metabolomic analysis.
• Presence of chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
• Use of antibiotics, probiotics, or prebiotics within 4 weeks prior to sample collection.
• Pregnant or breastfeeding women.
• Refusal or inability to provide informed consent.

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

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)