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Completed

NCT Number: NCT06404593

Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Before implementing any trial-related procedures, written informed consent should be signed;
  • >=20 and <= 85 years old, male or female;
  • Patients with liver metastases pathologically confirmed as colorectal adenocarcinoma;
  • 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;
  • The multidisciplinary team (MDT) confirmed that the liver metastases were initially resectable ,without locally treatable extrahepatic metastases;
  • The general physical condition is good (ECOG score 0-1);
  • Life expectancy of more than 3 months;
  • There is no obvious symptoms of primary bleeding, obstruction and other indications for emergency surgery;
  • adequate organ function;
  • samples meet NGS quality control requirements;
  • 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

  • Patients who are intolerant to systemic chemotherapy or surgery;
  • Patients with multiple primary lesions;
  • 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.);
  • Excessive tissue necrosis after conversion therapy, making it impossible to sample according to testing requirements
  • Patients who have not undergone surgery after conversion therapy, only receiving radiofrequency ablation or chemotherapy follow-up
  • Not all metastatic lesions were resected after conversion therapy, or liver metastatic lesions did not achieve R0 resection
  • No definite mutations detected in the tissue, or mutations detected in tumor tissue were not covered by the designed small panel.

Treatment and study plan

Blood sampling

Diagnostic Test

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.

Primary outcomes

  1. progression-free survival

    Time frame: 1 year

  2. overall survival

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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