Colorectal Cancer, ctDNA, MRD
Conditions
Brief summary
This observational study aims to evaluate the predictive performance of various omics-based methods for detecting minimal residual disease (MRD) in stage III colorectal cancer. The study involves the collection of blood samples from patients who have accepted surgery for colorectal cancer. Blood samples will be analyzed using both tumor-informed and tumor-agnostic approaches to detect circulating tumor DNA (ctDNA). The study will compare the sensitivity of these methods and assess their correlation with recurrence risk. The findings aim to inform the development of optimal MRD detection strategies, ultimately providing a robust molecular basis for personalized treatment decisions.
Interventions
DIAGNOSTIC_TESTMRD detection
Baseline blood samples, surgical resected tumor tissue, blood samples after surgery, and blood samples after adjuvant therapy will be collected from colorectal patients. MRD will be assessed using both tumor-informed and tumor-agnostic methods.
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Histologically confirmed colorectal cancer. * Preoperatively assessed as stage III according to the 8th edition UICC/AJCC staging system. * Deemed eligible for radical resection upon investigator assessment. * No prior anti-tumor therapy received. * ECOG PS score 0-1. * Willing and able to provide signed informed consent for participation in the study.
Exclusion criteria
* Has a history of other malignant tumors. * Pregnant and lactating women. * Presence of any concurrent medical or psychiatric condition, as assessed by the investigator, that may interfere with protocol compliance, study follow-up, or affect short-term survival.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The predictive role of MRD in prognosis | 3 years | The survival difference between MRD positive and MRD negative patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The positive detection rate of baseline ctDNA | 1 year | — |
| Predictive Accuracy of MRD for Recurrence | 3 years | Sensitivity, Specificity, Positive predictive value, and Negative predictive value of ctDNA-MRD in predicting postoperative recurrence |
Countries
China
Contacts
Primary ContactFeng Wang
Outcome results
None listed