Colorectal Cancer (MSI-H)NCT07063550
Microplastics in Paraneoplastic and Intratumoral for Colorectal Cancer
An observational study of Colorectal Cancer (MSI-H) and Microplastic Exposure, run by Dong Peng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (MSI-H), Microplastic Exposure
- What is being tested?
- exposure to microplastic
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with colorectal cancer and received rectal cancer surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Identification of Paraneoplastic and Intratumoral Microplastics in Colorectal Cancer and Their Association Analysis With Macrogenomics and Metabolomics
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
- Being tested
- exposure to microplastic
- Keywords
- colorectal cancer, microplastic, Paraneoplastic, Genomics, Metabolomics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to microplasticOther
Microplastic content in cancerous and paracancerous tissues
| Study group | Role | What they receive |
|---|---|---|
| the colorectal cancer group | patients diagnosed with colorectal cancer Receives: Other: exposure to microplastic |
What is being measured
The primary outcome is the main question the study is designed to answer.
genomics
Genomics was tested by preoperative blood specimens.
Measured: Blood specimens were obtained within one week prior to surgery.
Secondary outcomes (1)
metabolomics
Metabolomics was tested by preoperative blood specimens.
Measured: Blood specimens were obtained within one week prior to surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Dec 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Dong Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063550
- Sponsor's protocol ID
- 2024-531-01
- Status last verified
- Dec 2024
- First submitted
- 3 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the requirements of the Ethics Committee, it was not permitted to make the acquired data public.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Paraneoplastic and Intratumoral Microplastics in Colorectal Cancer and Their Association Analysis With Macrogenomics and Metabolomics
- ClinicalTrials.gov ID
- NCT07063550
- Acronym / sponsor ID
- 2024-531-01
- Conditions
- Colorectal Cancer (MSI-H), Microplastic Exposure
- Keywords
- colorectal cancer, microplastic, Paraneoplastic, Genomics, Metabolomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the colorectal cancer group | – | Other: exposure to microplasticpatients diagnosed with colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with colorectal cancer and received rectal cancer surgery
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to microplasticMicroplastic content in cancerous and paracancerous tissues | Other | the colorectal cancer group |
Primary outcome
genomics
Time frame: Blood specimens were obtained within one week prior to surgery.
Genomics was tested by preoperative blood specimens.
1 secondary outcome
metabolomics
Time frame: Blood specimens were obtained within one week prior to surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. Due to the requirements of the Ethics Committee, it was not permitted to make the acquired data public.
Related trials for Colorectal Cancer (MSI-H)
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors
Advanced Solid Tumors, MSI-H or dMMR Advanced Solid Tumors
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Active, not recruitingPhase 3
Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (MSI-H) and Microplastic Exposure, run by Dong Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genomics (time frame: Blood specimens were obtained within one week prior to surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.