Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases

May 5, 2024 updated by: Peking University Cancer Hospital & Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study enrolled patients with colorectal liver metastases undergoing radical resection at Hepatopancreatobiliary Surgery Department I of Peking University Cancer Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Blood sampling 7 days after surgery
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.
Group 2
Blood sampling 1 month after surgery
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.
Group 3
Blood sampling 3 to 6 months after surgery
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.
Group 4
Blood sampling 6 to 9 months after surgery
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.
Group 5
Blood sampling 9 to 12 months after surgery
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival
Time Frame: 5 year
5 year
progression-free survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PKUCRLM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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