Colorectal Cancer Clinical Trial
Official title:
Dynamic Monitoring of Circulating Tumor DNA Methylation to Predict Relapse in Colorectal Cancer After Radical Resection: A Prospective, Multicenter, Clinical Study (POSTCA)
This is a prospective, multicenter, observational, single-blinded controlled study. Dynamic monitoring of patients with resectable colorectal cancer was performed using the previously established colorectal tumor-specific plasma ctDNA methylation markers (Multigene methylation detection). Dynamic monitoring of plasma ctDNA methylation before and after treatment and at regular follow-up in patients with colorectal cancer after radical resection of tumor, to explore the predictive effect of postoperative plasma ctDNA methylation on postoperative recurrence and whether dynamic monitoring of postoperative ctDNA methylation could be earlier than imaging examination to indicate tumor recurrence.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female = 18 years of age on the day of signing informed consent. - Patients must have histologically confirmed colorectal cancer. - Patients need to receive surgical resection. - Patients must have a performance status of =1 on the ECOG Performance Scale. - Life expectancy of more than 5 years. - Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study. Exclusion Criteria: - Patients received adjuvant treatment prior to the surgical resection. - Patients received blood transfusion two weeks before or during the surgical resection. - Patients with unresected advanced colorectal adenoma. - Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C. - Patients who are pregnant. - Patients who are alcoholic or drug abusers. - Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University | Hebei Medical University Fourth Hospital, RenJi Hospital, Second Military Medical University, Shanghai University of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Free Survival (DFS) | The primary endpoint for this study is Disease Free Survival (DFS), which will be assessed using RECIST version 1.1. | 2-year DFS | |
Primary | ctDNA methylation markers versus CT/MRI | ctDNA methylation predictors of outcome will be compared to CT/MRI | 2 years |
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