Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fudan University
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients who have been histopathologically diagnosed with colorectal adenocarcinoma;
Patients who have undergone radical curative resection of the primary tumors;
Patients with CRC of high-risk stage II and stage III based on final findings (UICC TNM Classification, 8th Edition);
Patients who tested positive for ctDNA methylation at 5-7 days after surgery prior to enrollment;
Patients with no obvious relapse confirmed by chest, abdominal, and pelvic CT scans, etc.;
Patients aged ≥ 18 and ≤80 years old, regardless of gender;
Patients with expected survival of more than 12 months;
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
Patients who have no severe disorder in major organs (such as the bone marrow, heart, lungs, liver, and kidneys) and meet the following criteria: Neutrophil count ≥ 1,500/mm3, Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 8.0 g/dL, Serum creatinine ≤ 1.5 mg/dL, Total bilirubin ≤ 1.5 mg/dL, ALT and AST ≤ 100 U/L
Patients with no diarrhea or stomatitis of Grade 2 or severer according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0;
Patients who voluntarily gave written consent to participate in the trial after receiving a thorough explanation of the trial before enrolling in the trial
You may not be if
Neoadjuvant therapy performed before operation;
Blood transfusion performed during operation or within 2 weeks before operation;
Incomplete baseline samples, including preoperative plasma samples and plasma samples 5-7 days after operation;
Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
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;
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;
Significant impairment of important organ function;
Other conditions in which the investigator believes that the patient should not participate in this trial
Clareo Health | Circulating Tumor DNA Methylation Guided Postoperative Adjuvant Chemotherapy for High-risk Stage II/III Colorectal Cancer
