Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence
NCT ID: NCT04506398
Last Updated: 2021-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2020-09-10
2022-08-31
Brief Summary
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According to the "Seed-Soil" theory, the primary hypothesis of this study is that HCC patients with different molecular-subtype experience altered different pattern of post-transplant recurrence, thus may have altered postoperative Recurrence-Free Survival (RFS). Because the donors' liver construct different microenvironment for CTC(circulating tumor cells) colonization. The investigators design this translational study to ①explore potential high recurrent risk HCC molecular-subtypes which might benefit from neoadjuvant systematic therapy or early adjuvant systematic therapy;②identify the molecular subtype heterogeneity of primary and recurrent HCC to guide the precision medicine.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Retrospective cohort
20 HCC patients experienced post-transplant HCC
liver transplant
Liver transplantation for hepatocellular carcinoma has the potential to eliminate both the tumor as well as the underlying cirrhosis and is the ideal treatment for HCC in cirrhotic liver as well as massive HCC in noncirrhotic liver.
whole exome sequencing
xome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence.
Perspective cohort
20 HCC patients who underwent liver transplant, the patients would be recruited if recurrence would be diagnosed \>6 months after liver transplant
liver transplant
Liver transplantation for hepatocellular carcinoma has the potential to eliminate both the tumor as well as the underlying cirrhosis and is the ideal treatment for HCC in cirrhotic liver as well as massive HCC in noncirrhotic liver.
ctDNA
Circulating Tumor DNA Correlates With Microvascular Invasion and Predicts Tumor Recurrence of Hepatocellular Carcinoma
whole exome sequencing
xome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence.
Interventions
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liver transplant
Liver transplantation for hepatocellular carcinoma has the potential to eliminate both the tumor as well as the underlying cirrhosis and is the ideal treatment for HCC in cirrhotic liver as well as massive HCC in noncirrhotic liver.
ctDNA
Circulating Tumor DNA Correlates With Microvascular Invasion and Predicts Tumor Recurrence of Hepatocellular Carcinoma
whole exome sequencing
xome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence.
Eligibility Criteria
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Inclusion Criteria
* Patients have post-transplant HCC recurrence(cohort 1), Indication for being an candidate in the waiting list for liver transplant according to multidisciplinary board evaluation(cohort 2)
* The time frame between liver transplant and diagnosis of post-transplant HCC recurrence\> 6 months
* No prior hepatectomy or systemic therapy or local therapy (TACE etc.)
Exclusion Criteria
* early recurrence(\<6 months)
* multiple organ transplantation
18 Years
80 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Hao Feng, M.D., Ph.D.
Role: STUDY_DIRECTOR
Dept. of Liver surgery, Renji Hospital, Medical School of Shanghai Jiaotong University
Locations
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Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Renji-IIT-2020-0007
Identifier Type: -
Identifier Source: org_study_id
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