Colorectal CancerNCT07068529
Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Colorectal Cancer：MetBio-CRC
An observational study of Colorectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
This prospective clinical observational study aims to construct a metabolite database specifically for colorectal cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in colorectal cancer… 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
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 1 Jul 2030
- How long will I take part?
- 5 Years
- 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: Patients with colorectal cancer and healthy individuals.
Who may be able to join
- Healthy Controls:
- Age ≥ 18 years;
- Signed informed consent and willingness to participate in the project.
- Colorectal Cancer:
- Age ≥ 18 years;
- Performance status (ECOG) score ≤ 1;
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- Histopathologically confirmed colorectal adenocarcinoma;
- No family history of hereditary cancer;
- No prior anti-tumor treatment;
- Availability of primary tumor tissue from surgery or biopsy that meets submission requirements;
- Availability of peripheral blood samples that meet submission requirements;
- Willingness and ability to sign the informed consent form to participate in the study.
Who cannot join
- Healthy Controls:
- Individuals at high risk for hereditary colorectal adenocarcinoma, including family members of the following diseases: family history of gastrointestinal tumors, familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC/LS), and Peutz-Jeghers syndrome (P-J syndrome);
- History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
- Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
- History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;
- Regular use of immunosuppressive drugs within the past 6 months;
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- Long-term use of other medications that may affect metabolism, such as hormones;
- Inability or unwillingness to cooperate with follow-up visits and related examinations;
- Inability to eat normally or requiring medications or enemas for bowel movements;
- Presence of psychiatric disorders or other severe cardiovascular diseases;
- Pregnant, breastfeeding, or planning to become pregnant within the next year;
- Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.
- Colorectal Cancer:
- A clear family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, etc.;
- Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;
- Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
- History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
- Presence of poorly controlled chronic comorbidities that may affect prognosis;
- Presence of psychiatric disorders or other severe cardiovascular diseases;
- Pregnant, breastfeeding, or planning to become pregnant within the next year;
- Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.;
- Any severe and/or uncontrolled medical conditions, as judged by the investigator, that may affect the patient's ability to participate in the study or interfere with study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital Shanghai Jiaotong University, School of Medicine
Shanghai, Shanghai Municipality, 200025
Jing Sun, MD, Ph.D., 11788@rjh.com.cn
About this study
Official title: Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Gastric Cancer：MetBio-CRC
This prospective clinical observational study aims to construct a metabolite database specifically for colorectal cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in colorectal cancer, thereby a establishing safe, convenient, and highly sensitive method for early screening and prognostic prediction.
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Metabolic Marker, Prognosis, Early Diagnosis
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | This group recruits healthy individuals which is intended to establish a metabolic biomarker baseline | |
| CRC | Colorectal cancer group, which is study of interest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The time from the start of treatment to death due to any cause.
Measured: 3 years
Disease-Free Survival
Disease-Free Survival (DFS) refers to the length of time after primary treatment for a disease during which the patient remains free of certain signs or symptoms of the disease. It is typically measured from the start of treatment until the first recurrence or relapse of the disease.
Measured: 3 years
Secondary outcomes (7)
Hazard Ratio
The hazard ratio is a measure of the relative risk of an event occurring in one group compared to another group. It is used to quantify the difference in the rate at which events occur between two groups, typically a treatment group and a control group.
Measured: 3 years
Positive Predictive Value
The Positive Predictive Value (PPV) indicates how likely it is that a person actually has the disease if the test result is positive.
Measured: 3 years
Negative Predictive Value
The Negative Predictive Value (NPV) indicates how likely it is that a person does not have the disease if the test result is negative.
Measured: 3 years
Assessment of Important Metabolic Biomarkers
Measured: 3 years
Recurrence and Metastasis Rate
Measured: 3 years
Cancer-Related Mortality
Measured: 3 years
Time to Recurrence and Metastasis and Specific Sites
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jun 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2030 (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
- 250 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068529
- Sponsor's protocol ID
- MetBio-CRC
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Gastric Cancer：MetBio-CRC
- ClinicalTrials.gov ID
- NCT07068529
- Acronym / sponsor ID
- MetBio-CRC
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Metabolic Marker, Prognosis, Early Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 16 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.
This prospective clinical observational study aims to construct a metabolite database specifically for colorectal cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in colorectal cancer, thereby a establishing safe, convenient, and highly sensitive method for early screening and prognostic prediction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | –This group recruits healthy individuals which is intended to establish a metabolic biomarker baseline |
| CRC | – | –Colorectal cancer group, which is study of interest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancer and healthy individuals.
Key inclusion criteria (12 listed)
- Healthy Controls:
- Colorectal Cancer:
- Age ≥ 18 years;
- Performance status (ECOG) score ≤ 1;
- Histopathologically confirmed colorectal adenocarcinoma;
Key exclusion criteria (22 listed)
- Healthy Controls:
- Colorectal Cancer:
- A clear family history of hereditary colorectal cancer, such as Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers syndrome, etc.;
- Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;
- Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 3 years
The time from the start of treatment to death due to any cause.
Disease-Free Survival
Time frame: 3 years
Disease-Free Survival (DFS) refers to the length of time after primary treatment for a disease during which the patient remains free of certain signs or symptoms of the disease. It is typically measured from the start of treatment until the first recurrence or relapse of the disease.
7 secondary outcomes
Hazard Ratio
Time frame: 3 years
Positive Predictive Value
Time frame: 3 years
Negative Predictive Value
Time frame: 3 years
Assessment of Important Metabolic Biomarkers
Time frame: 3 years
Recurrence and Metastasis Rate
Time frame: 3 years
Cancer-Related Mortality
Time frame: 3 years
Time to Recurrence and Metastasis and Specific Sites
Time frame: 3 years
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 Jul 2025.
- 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.
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, run by Shanghai Minimally Invasive Surgery Center 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 12 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 16 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?
Contact Jing Sun (+86-13524284622, sj117788@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). The study lists 2 primary outcomes in all. 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 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.