Metastatic Colorectal Cancer ctDNA SurveillanceNCT07283575
Using ctDNA Methylation to Monitor Metastatic Colorectal Cancer Treatment (PROMET)
An observational study of Metastatic Colorectal Cancer ctDNA Surveillance, run by Fudan University at 1 site in China.
Trial summary
Multi-center observational clinical study to evaluate the application value of ctDNA methylation monitoring in efficacy assessment and relapse prediction in patients diagnosed with recurrence or metastatic colorectal cancer receiving radiotherapy plus SOC with or without PD-1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer ctDNA Surveillance
- What is being tested?
- Plasma ctDNA methylation profiling
- How many people
- 497 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 10 Oct 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically confirmed, recurrent or metastatic colorectal cancer who are eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors.
Who may be able to join
- Age ≥ 18 years old, regardless of gender;
- Histologically confirmed, recurrent or metastatic colorectal cancer;
- Eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors.
- With expected survival of more than 6 months;
- The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.
Who cannot join
- Blood transfusion performed during operation or within 2 weeks before operation;
- Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
- Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer;
- Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms;
- Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency;
- Significant impairment of important organ function;
- Other conditions in which the investigator believes that the patient should not participate in this trial.
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
Fudan University Shanghai Cancer Center
Shanghai
Zhen Zhang, MD, PHD, 18801735029, zhen_zhang@fudan.edu.cn
About this study
Official title: ctDNA Methylation for Efficacy Assessment and Prognostic Prediction in Advanced Colorectal Cancer Treated With Radiotherapy Combined With or Without PD-1 Inhibitor: A Prospective Cohort Study (PROMET)
Multi-center observational clinical study to evaluate the application value of ctDNA methylation monitoring in efficacy assessment and relapse prediction in patients diagnosed with recurrence or metastatic colorectal cancer receiving radiotherapy plus SOC with or without PD-1.
Read the detailed description
This study will enroll patients with histologically confirmed, recurrent or metastatic colorectal cancer who are eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors. The study will employ ctDNA methylation detection technology to quantitatively assess ctDNA methylation levels in patient plasma samples. Blood samples will be collected at baseline and at multiple predefined timepoints during treatment. In addition, participants will undergo standard imaging surveillance (CT/MRI) every three months. The study aims to correlate ctDNA dynamics with therapeutic response, time to recurrence, and survival outcomes. Ultimately, it seeks to evaluate the potential of ctDNA monitoring for predicting treatment efficacy and prognosis, and to explore its utility in guiding clinical management for metastatic colorectal cancer.
- Being tested
- Plasma ctDNA methylation profiling
- Keywords
- Metastatic Colorectal Cancer(mCRC), Radiotherapy, Immunotherapy, ctDNA methylation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma ctDNA methylation profilingDiagnostic test
Plasma ctDNA methylation profiling was performed using an optimized single-tube multiplex mqMSP assay
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Newly diagnosed, histologically confirmed, recurrent or metastatic colorectal cancer, amenable to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors.
Patients will receive dynamic monitoring of ctDNA + routine follow-up: ctDNA detection is performed at baseline, multiple predefined timepoints during treatment and follow-up for a period of 2 years. At the same time, participants will undergo routine imaging surveillance (CT/MRI) every three months. Receives: Diagnostic Test: Plasma ctDNA methylation profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
To investigate ctDNA-based disease-free survival (ctDNA-DFS), CT-based disease-free survival (CT-DFS), and the difference between ctDNA-DFS and CT-DFS (△-DFS).
Measured: up to 2 years
Secondary outcomes (2)
OS
To exam whether 3- and 5-year overall survival (OS) with ctDNA-guided surveillance is comparable to that achieved with standard CT-based monitoring.
Measured: up to 5 year
Patient-reported outcomes (quality of life)
To assess patient-reported outcomes-quality of life (EORTC QLQ-C30)-in those receiving ctDNA-guided versus standard surveillance.
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start10 Oct 2025
- Primary completion10 Oct 2028 (estimated)
- Study completion10 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer ctDNA SurveillanceStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 497 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283575
- Sponsor's protocol ID
- 2025-364-4513
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA Methylation for Efficacy Assessment and Prognostic Prediction in Advanced Colorectal Cancer Treated With Radiotherapy Combined With or Without PD-1 Inhibitor: A Prospective Cohort Study (PROMET)
- ClinicalTrials.gov ID
- NCT07283575
- Acronym / sponsor ID
- 2025-364-4513
- Keywords
- Metastatic Colorectal Cancer(mCRC), Radiotherapy, Immunotherapy, ctDNA methylation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 497 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 10 Oct 2030 (estimated)
- First posted
- 16 Dec 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.
Multi-center observational clinical study to evaluate the application value of ctDNA methylation monitoring in efficacy assessment and relapse prediction in patients diagnosed with recurrence or metastatic colorectal cancer receiving radiotherapy plus SOC with or without PD-1.
Detailed description
This study will enroll patients with histologically confirmed, recurrent or metastatic colorectal cancer who are eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors. The study will employ ctDNA methylation detection technology to quantitatively assess ctDNA methylation levels in patient plasma samples. Blood samples will be collected at baseline and at multiple predefined timepoints during treatment. In addition, participants will undergo standard imaging surveillance (CT/MRI) every three months. The study aims to correlate ctDNA dynamics with therapeutic response, time to recurrence, and survival outcomes. Ultimately, it seeks to evaluate the potential of ctDNA monitoring for predicting treatment efficacy and prognosis, and to explore its utility in guiding clinical management for metastatic colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Diagnostic Test: Plasma ctDNA methylation profilingNewly diagnosed, histologically confirmed, recurrent or metastatic colorectal cancer, amenable to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors. Patients will receive dynamic monitoring of ctDNA + routine follow-up: ctDNA detection is performed at baseline, multiple predefined timepoints during treatment and follow-up for a period of 2 years. At the same time, participants will undergo routine imaging surveillance (CT/MRI) every three months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed, recurrent or metastatic colorectal cancer who are eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old, regardless of gender;
- Histologically confirmed, recurrent or metastatic colorectal cancer;
- Eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors.
- With expected survival of more than 6 months;
- The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.
Key exclusion criteria (7 listed)
- Blood transfusion performed during operation or within 2 weeks before operation;
- Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
- Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer;
- Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms;
- Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency;
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 |
|---|---|---|
| Plasma ctDNA methylation profilingPlasma ctDNA methylation profiling was performed using an optimized single-tube multiplex mqMSP assay | Diagnostic test | Experimental group |
Primary outcome
PFS
Time frame: up to 2 years
To investigate ctDNA-based disease-free survival (ctDNA-DFS), CT-based disease-free survival (CT-DFS), and the difference between ctDNA-DFS and CT-DFS (△-DFS).
2 secondary outcomes
OS
Time frame: up to 5 year
Patient-reported outcomes (quality of life)
Time frame: up to 5 year
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 Dec 2025.
- Individual participant dataSharing planned: No
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 Metastatic Colorectal Cancer ctDNA Surveillance, run by Fudan 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 5 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: looking for participants now, as of the sponsor's last update on 16 Dec 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 2 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 16 Dec 2025.