Independent Risk Factors Analysis and Model Construction For Recurrence After Radiofrequency/Microwave Ablation of Colorectal Cancer With Liver Metastases: a Retrospective, Multicenter Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer With Liver Metastases

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Zhongwei Zhao, Dr; Phone Number: 15925728781; Email: zhaozw79@163.com
• Study Contact Backup: Name: Dengke Zhang, Dr; Phone Number: 15957823142; Email: dk198646@163.com

Participation Criteria

Eligibility Criteria

• 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

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

Description

Inclusion Criteria:

1. Age：older than 18 years；
2. Patients with a single tumor diameter ≤5cm, no more than 3 tumor nodules, and the largest tumor diameter ≤3cm；
3. Absence of vessel, bile duct and adjacent organ invasion and distant metastasis;
4. 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);
5. Normal coagulation status and liver function child-pugh A or B;
6. Liver metastases have not received other antitumor therapy after radiofrequency/microwave therapy (before disease progression);
7. Routine laboratory tests were performed before the first RF/microwave treatment;
8. Follow up for more than 12 months;
9. Obtained free informed consent.

Exclusion Criteria:

1. Large tumor, or diffuse intrahepatic metastasis;
2. Accompanied by vascular tumor thrombus or invasion of adjacent organs;
3. The primary tumor of colorectal cancer has not been resected, with extrahepatic metastasis;
4. Uncorrectable coagulation dysfunction and severe blood abnormalities, those with severe bleeding tendency;
5. Intractable massive ascites, cachexia;
6. Active infection, especially inflammation of the biliary system;
7. Severe liver, kidney, heart, lung, brain and other major organ failure;
8. Patients with impaired consciousness or unable to cooperate with treatment;
9. Missing follow-up data.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time from enrollment to disease recurrence, assessed up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time from enrollment to developed new metastases, assessed up to 18 months

Collaborators and Investigators

• Sponsor: The Central Hospital of Lishui City
• Collaborators: Zhejiang Cancer Hospital; Zhejiang University; First Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 12, 2022
• Primary Completion (Anticipated): May 12, 2022
• Study Completion (Anticipated): August 12, 2022

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Recurrence; colorectal cancer with liver metastases; Radiofrequency/Microwave
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Recurrence; Liver Neoplasms
• Other Study ID Numbers: ZJLS-KLDMIR-22005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
• IPD Sharing Time Frame: Within six months after the trial is completed.
• IPD Sharing Access Criteria: Shared data is not available for downloading, but can only be browsed. To download the data, you must contact the researchers. Shared data does not provide any private information of the participants.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No