Fact CheckerSign in

NCT06404593Completed

Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases

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

Source: ClinicalTrials.gov · Last updated 8 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
270 (actual)
First submitted
5 May 2024
Start date
Jun 2019
Primary completion date
Dec 2023
Lead sponsor
Peking University Cancer Hospital & Institute
NCT number
NCT06404593

What you commit to

  • Study type: Observational
  • Participants enrolled: 270
  • From Jun 2019 to the primary completion date, Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who are intolerant to systemic chemotherapy or surgery;
  • 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

Other

  • 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.);
  • No definite mutations detected in the tissue, or mutations detected in tumor tissue were not covered by the designed small panel.

Who the study is looking for

  • 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.

Age in the registry: 20 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Cancer Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.