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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06404593
Other study ID # PKUCRLM-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 18, 2019
Est. completion date December 31, 2023

Study information

Verified date May 2024
Source Peking University Cancer Hospital & Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Blood 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.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary progression-free survival 1 year
Primary overall survival 5 year
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