Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases

Colorectal Cancer Clinical Trial

Official title:

Dynamic ctDNA Detection for Guiding Adjuvant Therapy and Recurrence Monitoring After Curative Resection of Colorectal Cancer Liver Metastases: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06404593
• Other study ID #: PKUCRLM-1
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Circulating Tumor DNA
• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Minimal Residual Disease
• Neoplasm Metastasis
• Neoplasm, Residual
• Surgery

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