KRAS GeneNCT04417010
To Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation
An observational study of KRAS Gene and Colorectal Cancer, run by Peking University Cancer Hospital & Institute.
Trial summary
To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver metastases with different KRAS gene status Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS Gene, Colorectal Cancer, Liver Metastasis
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Men or women 18 years of age or older
Who may be able to join
- Diagnosed as liver metastasis of colorectal cancer;
- 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;
- The primary lesion of colorectal cancer has been treated curatively or is planned to undergo curative treatment;
- KRAS gene test results can be obtained for primary or metastatic foci;
- Signing informed consent voluntarily;
- Men or women who have reached the age of 18;
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- Ultrasound or ultrasound contrast can clearly show the lesion and guide RFA treatment;
- Platelet count> 50,000/mm3, prothrombin activity> 50%;
- Child-Pugh grade A or B of liver disease, but no hepatic encephalopathy or/and ascites;
- Subjects are willing to return to the research center for research follow-up;
- Life expectancy ≥ 6 months-
Who cannot join
- 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;
- During pregnancy or lactation. Before receiving research treatment, women of childbearing age must have a negative serum pregnancy test;
- Any known allergic reactions to the intravenous imaging agent used in this study;
- There is portal vein or hepatic vein tumor infiltration/carcinoma;
- International normalized ratio of prothrombin> 1.5 times the upper limit of normal value (UNL) of the research center;
- Platelet count <50,000/mm3, absolute neutrophil count <1500/mm3, or heme value <10.0g/dL;
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- Serum creatinine ≥2.5mg/dL or calculated creatinine clearance (CrCl) ≤25.0ml/min;
- Serum bilirubin>3.0mg/dL;
- Serum albumin <2.8g/dL;
- Body temperature >101°F (38.3°C) immediately before study treatment;
- being treated with other research drugs;
- Heart failure NYHA function grade is III or IV .
About this study
Official title: 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
- Being tested
- Radiofrequency ablation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Both groups of patients underwent radiofrequency ablation
What is being measured
The primary outcome is the main question the study is designed to answer.
local tumor progression
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
Measured: 2020-06-01-2023-05-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS GeneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Yan, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417010
- Sponsor's protocol ID
- 2020-2-2152
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT04417010
- Acronym / sponsor ID
- 2020-2-2152
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver metastases with different KRAS gene status
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men or women 18 years of age or older
Key inclusion criteria (11 listed)
- Diagnosed as liver metastasis of colorectal cancer;
- 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;
- The primary lesion of colorectal cancer has been treated curatively or is planned to undergo curative treatment;
- KRAS gene test results can be obtained for primary or metastatic foci;
- Signing informed consent voluntarily;
Key exclusion criteria (12 listed)
- 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;
- During pregnancy or lactation. Before receiving research treatment, women of childbearing age must have a negative serum pregnancy test;
- Any known allergic reactions to the intravenous imaging agent used in this study;
- There is portal vein or hepatic vein tumor infiltration/carcinoma;
- International normalized ratio of prothrombin> 1.5 times the upper limit of normal value (UNL) of the research center;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationBoth groups of patients underwent radiofrequency ablation | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of KRAS Gene and Colorectal Cancer, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local tumor progression (time frame: 2020-06-01-2023-05-31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.