NCT07283575 Using ctDNA Methylation to Monitor Metastatic Colorectal Cancer Treatment (PROMET)
| NCT ID | NCT07283575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Metastatic Colorectal Cancer ctDNA Surveillance |
| Study Type | OBSERVATIONAL |
| Enrollment | 497 participants |
| Start Date | 2025-10-10 |
| Primary Completion | 2028-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 497 participants in total. It began in 2025-10-10 with a primary completion date of 2028-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07283575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metastatic Colorectal Cancer ctDNA Surveillance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07283575 currently recruiting?
Yes, NCT07283575 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fudan University to inquire about joining.
Where is the NCT07283575 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07283575 clinical trial?
NCT07283575 is sponsored by Fudan University. The trial plans to enroll 497 participants.
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