Colorectal CancerNCT06643429
Impact of Environmental Factors and Metabolomics on Colorectal Cancer.
An observational study of Colorectal Cancer and Metabolic Disease, run by Dong Peng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Metabolic Disease
- What is being tested?
- colorectal cancer and colorectal neoplasm
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients diagnosed with colorectal cancer and undergoing radical surgery for colorectal cancer at the study centre.
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
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: Impact of Environmental Factors and Metabolomics on Colorectal Cancer Development and Prognosis Based on Environmental Factors and Metabolomics.
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.
Read the 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
- Being tested
- colorectal cancer, colorectal neoplasm
- Keywords
- colorectal cancer, air pollution, metabolomics, intestinal flora
- Medical subject headings
- Colorectal Neoplasms, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colorectal cancerDiagnostic test
Patients diagnosed with colorectal cancer by pathological biopsy.
colorectal neoplasmDiagnostic test
Patients diagnosed with colorectal adenoma confirmed by colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: colorectal cancer | |
| the colorectal adenoma group | Patients with preoperative diagnosis of colorectal adenoma confirmed by colonoscopy. Receives: Diagnostic Test: colorectal neoplasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative complications
Surgical complications was defined as any postoperative complication occurring during the postoperative hospitalisation period.
Measured: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Secondary outcomes (1)
Overall survival
Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
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
- NCT06643429
- Sponsor's protocol ID
- 2024-222-02
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Environmental Factors and Metabolomics on Colorectal Cancer Development and Prognosis Based on Environmental Factors and Metabolomics.
- ClinicalTrials.gov ID
- NCT06643429
- Acronym / sponsor ID
- 2024-222-02
- Conditions
- Colorectal Cancer, Metabolic Disease
- Keywords
- colorectal cancer, air pollution, metabolomics, intestinal flora
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 16 Oct 2024 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the control group | – | –Adults with no history of malignancy and willing to participate in this study. |
| the colorectal cancer group | – | Diagnostic Test: colorectal cancerPatients with preoperative diagnosis of colorectal cancer confirmed by pathological biopsy. |
| the colorectal adenoma group | – | Diagnostic Test: colorectal neoplasmPatients with preoperative diagnosis of colorectal adenoma confirmed by colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients diagnosed with colorectal cancer and undergoing radical surgery for colorectal cancer at the study centre.
Key inclusion criteria (10 listed)
- Healthy control group:
- Gastric cancer group:
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| colorectal cancerPatients diagnosed with colorectal cancer by pathological biopsy. | Diagnostic test | the colorectal cancer group |
| colorectal neoplasmPatients diagnosed with colorectal adenoma confirmed by colonoscopy. | Diagnostic test | the colorectal adenoma group |
Primary outcome
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.
1 secondary outcome
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.
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 16 Oct 2024.
- Individual participant dataSharing planned: No
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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 and Metabolic Disease, 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 10 inclusion and 3 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 16 Oct 2024. 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?
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.). 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 16 Oct 2024.