To Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation

June 4, 2020 updated by: Kun Yan, Peking University Cancer Hospital & Institute

A Prospective Study to Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation

To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver metastases with different KRAS gene status

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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 (Anticipated)

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.
163

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men or women 18 years of age or older

Description

Inclusion Criteria:

  1. Diagnosed as liver metastasis of colorectal cancer;
  2. There are no more than 3 liver metastases and all the lesions are not more than 5 cm; or no more than 6 liver metastases and all the lesions are not more than 3.0 cm;
  3. The primary lesion of colorectal cancer has been treated curatively or is planned to undergo curative treatment;
  4. KRAS gene test results can be obtained for primary or metastatic foci;
  5. Signing informed consent voluntarily;
  6. Men or women who have reached the age of 18;
  7. Ultrasound or ultrasound contrast can clearly show the lesion and guide RFA treatment;
  8. Platelet count> 50,000/mm3, prothrombin activity> 50%;
  9. Child-Pugh grade A or B of liver disease, but no hepatic encephalopathy or/and ascites;
  10. Subjects are willing to return to the research center for research follow-up;
  11. Life expectancy ≥ 6 months-

Exclusion Criteria:

  1. suffer from but not limited to the following serious diseases: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening arrhythmia in the past 6 months;
  2. During pregnancy or lactation. Before receiving research treatment, women of childbearing age must have a negative serum pregnancy test;
  3. Any known allergic reactions to the intravenous imaging agent used in this study;
  4. There is portal vein or hepatic vein tumor infiltration/carcinoma;
  5. International normalized ratio of prothrombin> 1.5 times the upper limit of normal value (UNL) of the research center;
  6. Platelet count <50,000/mm3, absolute neutrophil count <1500/mm3, or heme value <10.0g/dL;
  7. Serum creatinine ≥2.5mg/dL or calculated creatinine clearance (CrCl) ≤25.0ml/min;
  8. Serum bilirubin>3.0mg/dL;
  9. Serum albumin <2.8g/dL;
  10. Body temperature >101°F (38.3°C) immediately before study treatment;
  11. being treated with other research drugs;
  12. Heart failure NYHA function grade is III or IV .

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

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
Measure Description
Time Frame
local tumor progression
Time Frame: 2020-06-01-2023-05-31
the appearance of tumor foci at the edge of the ablation zones after at least one contrast-enhanced follow-up study has documented adequate ablation and covered by the ablation zone in the target tumor and surrounding ablation margin using imaging criteria
2020-06-01-2023-05-31

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 (Anticipated)

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 1, 2020

Primary Completion (Anticipated)

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.
May 31, 2023

Study Completion (Anticipated)

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.
May 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).
June 2, 2020

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.
June 2, 2020

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.
June 4, 2020

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.
June 9, 2020

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.
June 4, 2020

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.
June 1, 2020

More Information

Terms related to this study

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.
  • 2020-2-2152

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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