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By Developing a Radiomics Model to Predict the Prognosis of Patients With Hepatocellular Carcinoma After Microwave Ablation

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ClinicalTrials.gov Identifier: NCT03880721
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

Brief Summary:
Developing a radiomics model to predict the prognosis of patients with hepatocellular carcinoma after microwave ablation to provide advice for their treatment.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Procedure: Microwave abaltion

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: By Developing a Radiomics Model to Predict the Prognosis of Patients With Hepatocellular Carcinoma After Microwave Ablation
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : April 2021

Group/Cohort Intervention/treatment
Good prognosis Procedure: Microwave abaltion
Use microwave ablation to treat hepatocellular carcinoma

Poor prognosis Procedure: Microwave abaltion
Use microwave ablation to treat hepatocellular carcinoma

Recurrence Procedure: Microwave abaltion
Use microwave ablation to treat hepatocellular carcinoma

Not Recurrence Procedure: Microwave abaltion
Use microwave ablation to treat hepatocellular carcinoma

Survival Procedure: Microwave abaltion
Use microwave ablation to treat hepatocellular carcinoma

Death Procedure: Microwave abaltion
Use microwave ablation to treat hepatocellular carcinoma




Primary Outcome Measures :
  1. AUC value [ Time Frame: through study completion, an average of 2 year ]
    Utilizing area under curve to judge the accurency

  2. Sensitivity [ Time Frame: through study completion, an average of 2 year ]
    diagnosis sensitivity of intelligent ultrasound analysis

  3. Specificity [ Time Frame: through study completion, an average of 2 year ]
    diagnosis specificity of intelligent ultrasound analysis



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with primary hepatocellular carcinoma
Criteria

Inclusion Criteria:

  • Patients with primary hepatocellular carcinoma in the department of interventional ultrasound, PLA general hospital, who accept MWA therapy for HCC

Inclusion criteria:

  1. Primary hepatocellular
  2. No other treatments ware performed before microwave ablation
  3. Patient has been clinically diagnosed with HCC definitely, and have a definite operational indication
  4. No extrahepatic manifestations and no evidence of vessel invasion and bile duct thrombi

Exclusion Criteria:

  • Exclusion criteria:

    1. Non-primary hepatocellular carcinoma or hepatic metastases
    2. Accept other treatment before microwave ablation
    3. Extrahepatic metastasis, vessel invasion or bile duct thrombi

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880721


Contacts
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Contact: Jie Yu, Dr 8610-66939530 yu-jie301@hotmail.com
Contact: Ping Liang, Dr 8610-66939530 liangping301@hotmail.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Ping Liang, Doctor         
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Ping Liang, Prof., Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03880721     History of Changes
Other Study ID Numbers: 301jrcsk4
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ping Liang, Chinese PLA General Hospital:
radiomics
prognosis

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases