Colo-rectal CancerNCT07035262
Impact of Pre- and Post-operative Serum Metabolome Dynamics in Colorectal Resection Outcomes
An observational study of Colo-rectal Cancer, run by Dong Peng at 1 site in China.
Trial summary
The aim of this study is to systematically analyze the dynamic pattern of preoperative and postoperative serum metabolites in colorectal cancer patients through metabolomics technology, and to screen the key metabolites with statistical differences and explore their correlation with surgical interventions by combining… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- serum metabolites
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Sep 2025
- 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
Who may be able to join
- Previous consent to participate;
- Blood drawn and serum samples extracted and preserved both preoperatively and postoperatively;
- Successful detection of metabolomics profiles from serum samples;
- Acceptance of a standard radical colorectal cancer procedure;
- Complete perioperative data available;
- Adults with a pathologic diagnosis of colorectal cancer
Who cannot join
- Have or have had a previous history of other malignancies;
- Have a history of radiotherapy treatment;
- Have a history of inflammatory bowel disease;
- Have a familial history of genetic disorders;
- Missing baseline data (age, BMI, gender, previous medical history, etc.);
- Failed to leave the hospital earlier than medically indicated;
- Failed to sign an informed consent form.
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: Preoperative and Postoperative Changes in Serum Metabolome Dynamics in Colorectal Cancer Patients and Their Impact on Perioperative Clinical Outcomes
The aim of this study is to systematically analyze the dynamic pattern of preoperative and postoperative serum metabolites in colorectal cancer patients through metabolomics technology, and to screen the key metabolites with statistical differences and explore their correlation with surgical interventions by combining the baseline characteristics of the patients with the perioperative clinical data; to further reveal the impact of surgery on the body's metabolic remodeling pattern, and to explore the potential biomarkers and regulatory pathways, providing a theoretical basis for elucidating the metabolic mechanism. Investigaters will further reveal the impact of surgery on metabolic remodeling, explore potential biomarkers and regulatory pathways, provide theoretical basis for elucidating the metabolic mechanism, and evaluate its clinical translational value (e.g., postoperative monitoring, targeted intervention, etc.), so as to lay the foundation for the subsequent basic research and precise treatment strategies.
- Conditions
- Colo-rectal Cancer
- Being tested
- serum metabolites
- Keywords
- colorectal cancer, postoperative complication, surgery, metabolites
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum metabolitesOther
serum metabolites before and after colorectal cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| the colorectal cancer group | patients diagnosed with colorectal cancer Receives: Other: serum metabolites |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
Postoperative complications occurring within two months after surgery.
Measured: From the first day of surgery to two months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jan 2023
- Primary completion1 Jun 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
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
- NCT07035262
- Sponsor's protocol ID
- 2025-364-01
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethics committees require no data sharing due to patient privacy protection.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative and Postoperative Changes in Serum Metabolome Dynamics in Colorectal Cancer Patients and Their Impact on Perioperative Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07035262
- Acronym / sponsor ID
- 2025-364-01
- Conditions
- Colo-rectal Cancer
- Keywords
- colorectal cancer, postoperative complication, surgery, metabolites
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 25 Jun 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 aim of this study is to systematically analyze the dynamic pattern of preoperative and postoperative serum metabolites in colorectal cancer patients through metabolomics technology, and to screen the key metabolites with statistical differences and explore their correlation with surgical interventions by combining the baseline characteristics of the patients with the perioperative clinical data; to further reveal the impact of surgery on the body's metabolic remodeling pattern, and to explore the potential biomarkers and regulatory pathways, providing a theoretical basis for elucidating the metabolic mechanism. Investigaters will further reveal the impact of surgery on metabolic remodeling, explore potential biomarkers and regulatory pathways, provide theoretical basis for elucidating the metabolic mechanism, and evaluate its clinical translational value (e.g., postoperative monitoring, targeted intervention, etc.), so as to lay the foundation for the subsequent basic research and precise treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the colorectal cancer group | – | Other: serum metabolitespatients 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
Key inclusion criteria (6 listed)
- Previous consent to participate;
- Blood drawn and serum samples extracted and preserved both preoperatively and postoperatively;
- Successful detection of metabolomics profiles from serum samples;
- Acceptance of a standard radical colorectal cancer procedure;
- Complete perioperative data available;
Key exclusion criteria (7 listed)
- Have or have had a previous history of other malignancies;
- Have a history of radiotherapy treatment;
- Have a history of inflammatory bowel disease;
- Have a familial history of genetic disorders;
- Missing baseline data (age, BMI, gender, previous medical history, etc.);
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 |
|---|---|---|
| serum metabolitesserum metabolites before and after colorectal cancer surgery | Other | the colorectal cancer group |
Primary outcome
postoperative complications
Time frame: From the first day of surgery to two months after surgery
Postoperative complications occurring within two months after 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 25 Jun 2025.
- Individual participant dataSharing planned: No. Ethics committees require no data sharing due to patient privacy protection.
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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 Colo-rectal Cancer, 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 25 Jun 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?
postoperative complications (time frame: From the first day of surgery to two 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 25 Jun 2025.