Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures

NCT05393102 | Unknown

• 1 other identifier: 2022-20
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

As a prospective, multi-center study, GUIDER will recruit 400 liver nodules participants from different provinces and regions across China. Except for cfDNA signatures, serum biomarkers, histopathological biopsy and enhanced MRI will also be performed. The sensitivity and specificity of the cfDNA signature based-model in liver nodules diagnosing will be evaluated.

Conditions

Focal Liver Lesions

Keywords

hepatocellular carcinoma; liver nodules; auxiliary diagnosis; liquid biopsy; peripheral blood; cfDNA

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.

  Sensitivity is defined as the ratio of positively detected participants in all malignant nodule patients by cfDNA signatures.

  Enrollment of the first participant up to 18 months

• Specificity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.

  Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by cfDNA signatures.

  Enrollment of the first participant up to 18 months

Secondary Outcomes (1)

• Specificity of the model that composed of cfDNA signatures, imaging examination，serum protein markers and clinical characteristics in liver nodules diagnosis.

  Through study completion，an average of 18 months

Study Arms (3)

Malignant liver nodules cohort

Participants with malignant liver nodules diagnosed by pathological biopsy.

Other: No interventions

Benign liver nodules cohort

Participants with benign liver nodules diagnosed by pathological biopsy or imaging examination.

Other: 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.

Other: No interventions

Interventions

No interventions OTHER

No interventions

Benign liver nodules cohort; Malignant liver nodules cohort; Uncertain benign or malignant liver nodules cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Four hundreds eligible participants will be recruited from medical centers and assigned into three groups, including participants with malignant or benign liver nodules，and participants with uncertain liver nodules.

You may qualify if:

• Eighteen years or elder；
• 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.

You may not qualify if:

• Participants with different enhancement mode liver nodules that detected by enhanced MRI and without CEUS confirmation；
• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• Eastern Hepatobiliary Surgery Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (3)

The 2nd affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

Related Publications (4)

• 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.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 16369988 BACKGROUND

• 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.

  PMID: 17087938 BACKGROUND

• 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.

  PMID: 33589745 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Hong Ren, MD

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

• Hongyang Wang, MD

  Eastern Hepatobiliary Surgery Hospita

  PRINCIPAL INVESTIGATOR

• Jinlin Hou, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Ren, MD

CONTACT

13983888786; renhong0531@vip.sina.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 26, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)