Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases
NCT ID: NCT06404593
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
270 participants
OBSERVATIONAL
2019-06-18
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Blood sampling 7 days after surgery
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.
Group 2
Blood sampling 1 month after surgery
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.
Group 3
Blood sampling 3 to 6 months after surgery
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.
Group 4
Blood sampling 6 to 9 months after surgery
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.
Group 5
Blood sampling 9 to 12 months after surgery
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
85 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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PKUCRLM-1
Identifier Type: -
Identifier Source: org_study_id
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