Colorectal CancerNCT07254156
A Study of Tumor-Agnostic MRD Detection in Stage III Colorectal Cancer
An observational study of Colorectal Cancer and MRD, run by Sun Yat-sen University at 1 site in China.
Trial summary
This observational study aims to evaluate the predictive performance of various omics-based methods for detecting minimal residual disease (MRD) in stage III colorectal cancer. The study involves the collection of blood samples from patients who have accepted surgery for colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, MRD, ctDNA
- What is being tested?
- MRD detection
- How many people
- 229 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2025to 31 Dec 2028
- 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: A total of 229 patients newly diagnosed with stage III colorectal cancer.
Who may be able to join
- Age ≥ 18 years.
- Histologically confirmed colorectal cancer.
- Preoperatively assessed as stage III according to the 8th edition UICC/AJCC staging system.
- Deemed eligible for radical resection upon investigator assessment.
- No prior anti-tumor therapy received.
- ECOG PS score 0-1.
- Willing and able to provide signed informed consent for participation in the study.
Who cannot join
- Has a history of other malignant tumors.
- Pregnant and lactating women.
- Presence of any concurrent medical or psychiatric condition, as assessed by the investigator, that may interfere with protocol compliance, study follow-up, or affect short-term survival.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhida Lv, +86-020-8734-2635, lvzd@sysucc.org.cn
About this study
Official title: A Prospective, Multicenter, Exploratory Clinical Study Evaluating the Application of Tissue-Agnostic Technology in the Dynamic Monitoring of Minimal Residual Disease in Stage III Colorectal Cancer
This observational study aims to evaluate the predictive performance of various omics-based methods for detecting minimal residual disease (MRD) in stage III colorectal cancer. The study involves the collection of blood samples from patients who have accepted surgery for colorectal cancer. Blood samples will be analyzed using both tumor-informed and tumor-agnostic approaches to detect circulating tumor DNA (ctDNA). The study will compare the sensitivity of these methods and assess their correlation with recurrence risk. The findings aim to inform the development of optimal MRD detection strategies, ultimately providing a robust molecular basis for personalized treatment decisions.
- Conditions
- Colorectal Cancer, MRD, ctDNA
- Being tested
- MRD detection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRD detectionDiagnostic test
Baseline blood samples, surgical resected tumor tissue, blood samples after surgery, and blood samples after adjuvant therapy will be collected from colorectal patients. MRD will be assessed using both tumor-informed and tumor-agnostic methods.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stage III colorectal cancer | Not described Receives: Diagnostic Test: MRD detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive role of MRD in prognosis
The survival difference between MRD positive and MRD negative patients.
Measured: 3 years
Secondary outcomes (2)
The positive detection rate of baseline ctDNA
Measured: 1 year
Predictive Accuracy of MRD for Recurrence
Sensitivity, Specificity, Positive predictive value, and Negative predictive value of ctDNA-MRD in predicting postoperative recurrence
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 posted28 Nov 2025
- Study start24 Nov 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 229 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254156
- Sponsor's protocol ID
- TRACE-CRC
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Exploratory Clinical Study Evaluating the Application of Tissue-Agnostic Technology in the Dynamic Monitoring of Minimal Residual Disease in Stage III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07254156
- Acronym / sponsor ID
- TRACE-CRC
- Conditions
- Colorectal Cancer, MRD, ctDNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 229 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Nov 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 observational study aims to evaluate the predictive performance of various omics-based methods for detecting minimal residual disease (MRD) in stage III colorectal cancer. The study involves the collection of blood samples from patients who have accepted surgery for colorectal cancer. Blood samples will be analyzed using both tumor-informed and tumor-agnostic approaches to detect circulating tumor DNA (ctDNA). The study will compare the sensitivity of these methods and assess their correlation with recurrence risk. The findings aim to inform the development of optimal MRD detection strategies, ultimately providing a robust molecular basis for personalized treatment decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stage III colorectal cancer | – | Diagnostic Test: MRD detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 229 patients newly diagnosed with stage III colorectal cancer.
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Histologically confirmed colorectal cancer.
- Preoperatively assessed as stage III according to the 8th edition UICC/AJCC staging system.
- Deemed eligible for radical resection upon investigator assessment.
- No prior anti-tumor therapy received.
Key exclusion criteria (3 listed)
- Has a history of other malignant tumors.
- Pregnant and lactating women.
- Presence of any concurrent medical or psychiatric condition, as assessed by the investigator, that may interfere with protocol compliance, study follow-up, or affect short-term survival.
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 |
|---|---|---|
| MRD detectionBaseline blood samples, surgical resected tumor tissue, blood samples after surgery, and blood samples after adjuvant therapy will be collected from colorectal patients. MRD will be assessed using both tumor-informed and tumor-agnostic methods. | Diagnostic test | Patients with stage III colorectal cancer |
Primary outcome
The predictive role of MRD in prognosis
Time frame: 3 years
The survival difference between MRD positive and MRD negative patients.
2 secondary outcomes
The positive detection rate of baseline ctDNA
Time frame: 1 year
Predictive Accuracy of MRD for Recurrence
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 28 Nov 2025.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 and MRD, run by Sun Yat-sen University 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 7 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: opening soon, as of the sponsor's last update on 28 Nov 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 Feng Wang (+86-020-8734-3571, wangfeng@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive role of MRD in prognosis (time frame: 3 years). 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 28 Nov 2025.