Using ctDNA Methylation to Monitor Metastatic Colorectal Cancer Treatment (PROMET)

NCT ID: NCT07283575

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 497 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-10
• Study Completion Date: 2030-10-10

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.

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.

Conditions

Metastatic Colorectal Cancer ctDNA Surveillance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Plasma ctDNA methylation profiling

Intervention Type: DIAGNOSTIC_TEST

Plasma ctDNA methylation profiling was performed using an optimized single-tube multiplex mqMSP assay

Interventions

Plasma ctDNA methylation profiling

Plasma ctDNA methylation profiling was performed using an optimized single-tube multiplex mqMSP assay

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen Zhang

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhen Zhang, MD, PHD

Role: primary

zhen_zhang@fudan.edu.cn

18801735029

Other Identifiers

2025-364-4513

Identifier Type: -

Identifier Source: org_study_id