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NCT07283575Recruiting

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)

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
497 (estimated)
First submitted
4 Dec 2025
Start date
Oct 2025
Primary completion date
Oct 2028
Lead sponsor
Fudan University
NCT number
NCT07283575

What you commit to

  • Study type: Observational
  • Planned participants: 497
  • From Oct 2025 to the primary completion date, Oct 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Blood transfusion performed during operation or within 2 weeks before operation;
  • 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;

Other illness

  • 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;
  • Significant impairment of important organ function;
  • Other conditions in which the investigator believes that the patient should not participate in this trial.

Other

  • Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.