Plasma ctDNA Methylation Markers for Colorectal Cancer Recurrence Prediction
Data Collection
Collected from today forward - ProspectiveColonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 1, 2023
Actual date on which the first participant was enrolled.This clinical trial focuses on colorectal cancer patients who have peritoneal metastasis, a condition where the cancer spreads to the lining of the abdominal cavity. The main goal is to understand how a specific test, called ColonAiQ, can predict if the cancer will return after surgery. This test looks at the methylation status, a type of chemical modification, of ctDNA, a form of DNA found in the blood. The study is important as it could help improve the care for these patients by providing a way to predict cancer recurrence, allowing for earlier intervention and treatment. Participants in this study will have their blood tested for ctDNA methylation before and after surgery, and then every three months for up to two years. They will also have regular CT or MRI scans and blood tests for a protein called CEA, which can indicate the presence of cancer. If the cancer is detected to have returned, an additional blood sample will be taken. The study will then compare the results of the ColonAiQ test with the actual outcomes to see how well it predicts cancer recurrence.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: -1. No gender limit, age greater than 18 years old; 2, ECOG score ≤1; 3. Life expectancy ≥2 years; 4. Colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma confirmed by histopathology; 5, preoperative PCI score ≤20, peritoneal tumor cytoreductive surgery (CRS), surgery to achieve R0/1 resection; 6. Be able to understand the situation of this study and sign the informed consent. 7\. The primary colorectal cancer has undergone R0 resection, and there is no extraperitoneal metastasis (except ovary). Exclusion Criteria: * 1\. Combined with primary malignant tumors of other organs (current or within the past 5 years) (excluding patients with skin basal cell carcinoma and cervical carcinoma in situ undergoing radical treatment); 2. Severe mental illness or drug abuse; 3, severe heart, lung, vascular disease can not tolerate surgery; 4. Pregnant or lactating women.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fudan University Shanghai Cancer Center
Shanghai, ChinaOpen Fudan University Shanghai Cancer Center in Google Maps