Colorectal Cancer With Liver MetastasesNCT05268549
Independent Risk Factors Analysis and Model Construction For Recurrence After Radiofrequency/Microwave Ablation of Colorectal Cancer With Liver Metastases: a Retrospective, Multicenter Trial
An observational study of Colorectal Cancer With Liver Metastases, run by The Central Hospital of Lishui City.
Trial summary
This study is a retrospective, multicenter clinical study. The main objective is to analyze the risk factors affecting the recurrence of colorectal cancer patients with liver metastases who received radiofrequency/microwave ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer With Liver Metastases
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2022to 12 Aug 2022
- 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: This is a multicenter study. Patients from Lishui Central Hospital of Zhejiang Province, Zhejiang Cancer Hospital, the First Affiliated Hospital of Zhejiang University, the Second Affiliated Hospital of Zhejiang University, and the First Affiliated Hospital of Wenzhou Medical University who meet the above criteria will be included in this study
Who may be able to join
- Age：older than 18 years；
- Patients with a single tumor diameter ≤5cm, no more than 3 tumor nodules, and the largest tumor diameter ≤3cm；
- Absence of vessel, bile duct and adjacent organ invasion and distant metastasis;
- The primary tumor of colorectal cancer has been resected, the liver metastases cannot be resected or the patient is unwilling to undergo surgery (clinical or pathological confirmation);
- Normal coagulation status and liver function child-pugh A or B;
- Liver metastases have not received other antitumor therapy after radiofrequency/microwave therapy (before disease progression);
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- Routine laboratory tests were performed before the first RF/microwave treatment;
- Follow up for more than 12 months;
- Obtained free informed consent.
Who cannot join
- Large tumor, or diffuse intrahepatic metastasis;
- Accompanied by vascular tumor thrombus or invasion of adjacent organs;
- The primary tumor of colorectal cancer has not been resected, with extrahepatic metastasis;
- Uncorrectable coagulation dysfunction and severe blood abnormalities, those with severe bleeding tendency;
- Intractable massive ascites, cachexia;
- Active infection, especially inflammation of the biliary system;
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- Severe liver, kidney, heart, lung, brain and other major organ failure;
- Patients with impaired consciousness or unable to cooperate with treatment;
- Missing follow-up data.
Trial locations and contacts
No sites are listed yet.
About this study
This study is a retrospective, multicenter clinical study. The main objective is to analyze the risk factors affecting the recurrence of colorectal cancer patients with liver metastases who received radiofrequency/microwave ablation. Finally, we will construct a recurrence risk prediction model based on the risk factors and validated the model.
- Conditions
- Colorectal Cancer With Liver Metastases
- Keywords
- colorectal cancer with liver metastases, Radiofrequency/Microwave, Recurrence
- Medical subject headings
- Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months
The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months
Measured: Time from enrollment to disease recurrence, assessed up to 18 months
Secondary outcomes (1)
Patients with colorectal cancer with liver metastases (CRLM) developed new metastases after radiofrequency/microwave ablation,assessed up to 18 months
Patients with colorectal cancer with liver metastases (CRLM) developed new metastases after radiofrequency/microwave ablation,assessed up to 18 months
Measured: Time from enrollment to developed new metastases, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start12 Mar 2022 (estimated)
- Primary completion12 May 2022 (estimated)
- Study completion12 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer With Liver MetastasesStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Central Hospital of Lishui City
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Zhejiang University, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268549
- Sponsor's protocol ID
- ZJLS-KLDMIR-22005
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Risk Factors Analysis and Model Construction For Recurrence After Radiofrequency/Microwave Ablation of Colorectal Cancer With Liver Metastases: a Retrospective, Multicenter Trial
- ClinicalTrials.gov ID
- NCT05268549
- Acronym / sponsor ID
- ZJLS-KLDMIR-22005
- Conditions
- Colorectal Cancer With Liver Metastases
- Keywords
- colorectal cancer with liver metastases, Radiofrequency/Microwave, Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Central Hospital of Lishui CityUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Zhejiang University, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 12 Mar 2022 (estimated)
- Primary completion
- 12 May 2022 (estimated)
- Study completion
- 12 Aug 2022 (estimated)
- First posted
- 7 Mar 2022 (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.
This study is a retrospective, multicenter clinical study. The main objective is to analyze the risk factors affecting the recurrence of colorectal cancer patients with liver metastases who received radiofrequency/microwave ablation. Finally, we will construct a recurrence risk prediction model based on the risk factors and validated the model.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a multicenter study. Patients from Lishui Central Hospital of Zhejiang Province, Zhejiang Cancer Hospital, the First Affiliated Hospital of Zhejiang University, the Second Affiliated Hospital of Zhejiang University, and the First Affiliated Hospital of Wenzhou Medical University who meet the above criteria will be included in this study
Key inclusion criteria (9 listed)
- Age：older than 18 years；
- Patients with a single tumor diameter ≤5cm, no more than 3 tumor nodules, and the largest tumor diameter ≤3cm；
- Absence of vessel, bile duct and adjacent organ invasion and distant metastasis;
- The primary tumor of colorectal cancer has been resected, the liver metastases cannot be resected or the patient is unwilling to undergo surgery (clinical or pathological confirmation);
- Normal coagulation status and liver function child-pugh A or B;
Key exclusion criteria (9 listed)
- Large tumor, or diffuse intrahepatic metastasis;
- Accompanied by vascular tumor thrombus or invasion of adjacent organs;
- The primary tumor of colorectal cancer has not been resected, with extrahepatic metastasis;
- Uncorrectable coagulation dysfunction and severe blood abnormalities, those with severe bleeding tendency;
- Intractable massive ascites, cachexia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months
Time frame: Time from enrollment to disease recurrence, assessed up to 18 months
The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months
1 secondary outcome
Patients with colorectal cancer with liver metastases (CRLM) developed new metastases after radiofrequency/microwave ablation,assessed up to 18 months
Time frame: Time from enrollment to developed new metastases, assessed up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: Yes. Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer With Liver Metastases, run by The Central Hospital of Lishui City.
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 9 inclusion and 9 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 7 Mar 2022. 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?
Contact Zhongwei Zhao, Dr (15925728781, zhaozw79@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months (time frame: Time from enrollment to disease recurrence, assessed up to 18 months). 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 7 Mar 2022.