A Study of Tumor-Agnostic MRD Detection in Stage III Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRD detection.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, MRD, ctDNA. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multicenter, Exploratory Clinical Study Evaluating the Application of Tissue-Agnostic Technology in the Dynamic Monitoring of Minimal Residual Disease in Stage III Colorectal Cancer
Overview
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 test MRD 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.
Primary outcome measures
- The predictive role of MRD in prognosis [Time frame: 3 years]
Secondary outcome measures (2)
- The positive detection rate of baseline ctDNA [Time frame: 1 year]
- Predictive Accuracy of MRD for Recurrence [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07254156 · TRACE-CRC