Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures
NCT ID: NCT05393102
Last Updated: 2022-05-26
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
400 participants
OBSERVATIONAL
2022-05-31
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Malignant liver nodules cohort
Participants with malignant liver nodules diagnosed by pathological biopsy.
No interventions
No interventions
Benign liver nodules cohort
Participants with benign liver nodules diagnosed by pathological biopsy or imaging examination.
No interventions
No interventions
Uncertain benign or malignant liver nodules cohort
Participants with liver nodules could not be diagnosed definitely by imaging examination and serum protein markers.
No interventions
No interventions
Interventions
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No interventions
No interventions
Eligibility Criteria
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Inclusion Criteria
* Participants underwent enhanced MRI for the evaluation of liver nodules ≤5 cm；
* Participants whose platelet count ≥ 50×109/L, prothrombin activity (PTA) ≥ 60%；
* Participants who are willing and able to perform hepatectomy or tissure biopsy.
Exclusion Criteria
* Diagnosis of malignant tumors before recruitment；
* Anti-tumor therapy before recruitment ；
* HIV infection；
* Pregnancy；
* Allogenic blood transfusion or cell therapy within 14 days before peripheral blood samples collection;
* Participants with hepatic encephalopathy, hemangioma, ascites, gastrointestinal bleeding, jaundice, liver failure, congestive heart failure, or any other serious diseases that causing organ damage.
* Participants with any other factors that may leading to termination of the study.
18 Years
ALL
No
Sponsors
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Eastern Hepatobiliary Surgery Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
The Second Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Hong Ren
Clinical Professor
Principal Investigators
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Hong Ren, MD
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Chongqing Medical University
Hongyang Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Hepatobiliary Surgery Hospita
Jinlin Hou, MD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Kobayashi M, Ikeda K, Hosaka T, Sezaki H, Someya T, Akuta N, Suzuki F, Suzuki Y, Saitoh S, Arase Y, Kumada H. Dysplastic nodules frequently develop into hepatocellular carcinoma in patients with chronic viral hepatitis and cirrhosis. Cancer. 2006 Feb 1;106(3):636-47. doi: 10.1002/cncr.21607.
Llovet JM, Chen Y, Wurmbach E, Roayaie S, Fiel MI, Schwartz M, Thung SN, Khitrov G, Zhang W, Villanueva A, Battiston C, Mazzaferro V, Bruix J, Waxman S, Friedman SL. A molecular signature to discriminate dysplastic nodules from early hepatocellular carcinoma in HCV cirrhosis. Gastroenterology. 2006 Dec;131(6):1758-67. doi: 10.1053/j.gastro.2006.09.014. Epub 2006 Sep 19.
Chen L, Abou-Alfa GK, Zheng B, Liu JF, Bai J, Du LT, Qian YS, Fan R, Liu XL, Wu L, Hou JL, Wang HY; PreCar Team. Genome-scale profiling of circulating cell-free DNA signatures for early detection of hepatocellular carcinoma in cirrhotic patients. Cell Res. 2021 May;31(5):589-592. doi: 10.1038/s41422-020-00457-7. Epub 2021 Feb 15. No abstract available.
Other Identifiers
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2022-20
Identifier Type: -
Identifier Source: org_study_id
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