Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures (GUIDER)

May 24, 2022 updated by: Hong Ren, The Second Affiliated Hospital of Chongqing Medical University

Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome SignatuRes (GUDIER): an Observational Cohort Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with liver nodules will be recruited for 1 year. Peripheral blood samples of all participants will be collected after being informed about the study and potential risks. CfDNA extraction, library construction, and whole genome sequencing will be performed. A machine learning method will be implemented for cfDNA signatures-based model construction at the end of the study. Sensitivity and specificity will be used to evaluate the performance of cfDNA signatures-based model in liver nodules diagnosis.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • The 2nd affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital, Southern Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Malignant liver nodules cohort
Participants with malignant liver nodules diagnosed by pathological biopsy.
Other: No interventions
No interventions
Benign liver nodules cohort
Participants with benign liver nodules diagnosed by pathological biopsy or imaging examination.
Other: 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.
Other: No interventions
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.
Time Frame: Enrollment of the first participant up to 18 months
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.
Time Frame: Enrollment of the first participant up to 18 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of the model that composed of cfDNA signatures, imaging examination，serum protein markers and clinical characteristics in liver nodules diagnosis.
Time Frame: Through study completion，an average of 18 months
Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by the model that composed of cfDNA whole-genome signatures, imaging examination，serum protein markers， and clinical characteristics.
Through study completion，an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborators

Nanfang Hospital of Southern Medical University
Eastern Hepatobiliary Surgery Hospital

Investigators

  • Principal Investigator: Hongyang Wang, MD, Eastern Hepatobiliary Surgery Hospita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

May 8, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (ACTUAL)

May 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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