Clinical trial · Observational
Using ctDNA Methylation to Monitor Metastatic Colorectal Cancer Treatment (PROMET)
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)
NCT07283575CI-TRIAL-00099037recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer ctDNA Surveillance | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma ctDNA methylation profiling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Experimental group
- description
- 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.
- interventionNames
- Diagnostic Test: Plasma ctDNA methylation profiling
Primary outcomes (1)
- measure
- PFS
- timeFrame
- up to 2 years
- description
- 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).
Secondary outcomes (2)
- measure
- OS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old, regardless of gender; 2. Histologically confirmed, recurrent or metastatic colorectal cancer; 3. Eligible to receive radiotherapy in combination with standard-of-care chemotherapy, with or without PD-1 inhibitors. 4. With expected survival of more than 6 months; 5. 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. Exclusion Criteria: 1. Blood transfusion performed during operation or within 2 weeks before operation; 2. Pregnant or lactating women who have fertility and do not take adequate contraceptive measures; 3. Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer; 4. Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms; 5. 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; 6. Significant impairment of important organ function; 7. Other conditions in which the investigator believes that the patient should not participate in this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.