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出境医 / 临床实验 / Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation

Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation

Study Description
Brief Summary:
The purpose of this study is to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Liver Transplantation Magnetic Resonance Imaging Other: Risk model of tumor relapse

Detailed Description:
Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Liver transplantation is the most effective treatment for HCC and is in high demand in China. However, recurrence of HCC among liver transplantation recipients is still a great challenge and threat to the survival of recipients. So it is of great significance to establish a non-invasive way to filter high liver transplantation recipient population before transplantation. Based on large scales of pre-treatment MR images, the investigator's study aims to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population. This study will contribute to the precise selection of HCC-related liver transplantation recipients.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Relapse
Relapse of tumor within two years after liver transplantation
 Other: Risk model of tumor relapse
High risk factor model of tumor relapse after liver transplantation
Other Name: Risk model
Non-relapse
Non-relapse of tumor within two years after liver transplantation
 Other: Risk model of tumor relapse
High risk factor model of tumor relapse after liver transplantation
Other Name: Risk model
Outcome Measures
Primary Outcome Measures :
  1. tumor recurrent status [ Time Frame: two years ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospitalization patients
Criteria

Inclusion Criteria:

  • All patients had postoperative pathological diagnosis of HCC
  • All patients had underwent contrast-enhanced MRI scan within 2 weeks before liver transplantation

Exclusion Criteria:

  • patients whose pathological diagnosis is not HCC
  • patients whose CT images were affected by strong imaging artifacts, i.e. artifacts obscuring more than 10% of whole volume of interest
  • patients whose clinical data or CT images were missing
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date June 10, 2019
First Posted Date June 11, 2019
Last Update Posted Date June 11, 2019
Estimated Study Start Date July 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2019) 		tumor recurrent status [ Time Frame: two years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation
Official Title Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation
Brief Summary The purpose of this study is to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population
Detailed Description Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Liver transplantation is the most effective treatment for HCC and is in high demand in China. However, recurrence of HCC among liver transplantation recipients is still a great challenge and threat to the survival of recipients. So it is of great significance to establish a non-invasive way to filter high liver transplantation recipient population before transplantation. Based on large scales of pre-treatment MR images, the investigator's study aims to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population. This study will contribute to the precise selection of HCC-related liver transplantation recipients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population hospitalization patients
Condition
  • Hepatocellular Carcinoma
  • Liver Transplantation
  • Magnetic Resonance Imaging
Intervention Other: Risk model of tumor relapse
High risk factor model of tumor relapse after liver transplantation
Other Name: Risk model
Study Groups/Cohorts
  • Relapse
    Relapse of tumor within two years after liver transplantation
    Intervention: Other: Risk model of tumor relapse
  • Non-relapse
    Non-relapse of tumor within two years after liver transplantation
    Intervention: Other: Risk model of tumor relapse
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 10, 2019) 		200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients had postoperative pathological diagnosis of HCC
  • All patients had underwent contrast-enhanced MRI scan within 2 weeks before liver transplantation

Exclusion Criteria:

  • patients whose pathological diagnosis is not HCC
  • patients whose CT images were affected by strong imaging artifacts, i.e. artifacts obscuring more than 10% of whole volume of interest
  • patients whose clinical data or CT images were missing
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03981848
Other Study ID Numbers 2019ZJUXX-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Xiao Xu, Zhejiang University
Study Sponsor Zhejiang University
Collaborators Fudan University
Investigators Not Provided
PRS Account Zhejiang University
Verification Date June 2019

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