Circulating Tumor DNA, Colorectal Cancer, Liver Metastases, Minimal Residual Disease, Surgery
Conditions
Keywords
Minimal Residual Disease, Colorectal Liver Metastases
Brief summary
Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort underwent curative resection after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.
Interventions
DIAGNOSTIC_TESTBlood sampling
Evaluating the value of dynamic monitoring of a colorectal cancer liver metastasis cohort after receiving multipoint ctDNA detecting in predicting recurrence prognosis and guiding adjuvant chemotherapy treatment.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Before implementing any trial-related procedures, written informed consent should be signed; 2. \>=20 and \<= 85 years old, male or female; 3. Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma; 4. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging; 5. The multidisciplinary team (MDT) confirmed that the liver metastases were initially resectable ,without locally treatable extrahepatic metastases; 6. The general physical condition is good (ECOG score 0-1); 7. Life expectancy of more than 3 months; 8. There is no obvious symptoms of primary bleeding, obstruction and other indications for emergency surgery; 9. adequate organ function; 10. samples meet NGS quality control requirements; 11. The subjects are able and willing to comply with the visits, treatment plans, laboratory tests and other research-related procedures stipulated in the research protocol.
Exclusion criteria
1. Patients who are intolerant to systemic chemotherapy or surgery; 2. Patients with multiple primary lesions; 3. Blood samples and/or baseline tissue samples that do not meet the requirements for testing (hemolysis, low tumor cell content, insufficient DNA extraction yield, etc.); 4. Excessive tissue necrosis after conversion therapy, making it impossible to sample according to testing requirements 5. Patients who have not undergone surgery after conversion therapy, only receiving radiofrequency ablation or chemotherapy follow-up 6. Not all metastatic lesions were resected after conversion therapy, or liver metastatic lesions did not achieve R0 resection 7. No definite mutations detected in the tissue, or mutations detected in tumor tissue were not covered by the designed small panel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 1 year |
| overall survival | 5 year |
Countries
China
Outcome results
None listed