Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
1 other identifier
observational
2,000
1 country
3
Brief Summary
Most hepatocellular carcinoma (HCC) cases were at advanced stage when diagnosis established. This study is intended to establish a clinical diagnostic model GAMAD for early-stage HCC and evaluate the diagnostic efficiency the same time. This study is a multicenter prospective study. Participants including healthy control,HCC, liver cirrhosis, hepatitis and benign tumor-like lesions are consecutively recruited into the cohort. All the blood samples are collected before any treatments and will be tested in single center in order to decrease bias.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2022
CompletedFirst Submitted
Initial submission to the registry
November 15, 2022
CompletedFirst Posted
Study publicly available on registry
November 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 1, 2024
March 1, 2024
2 years
November 15, 2022
March 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GAMAD
Using GAMAD calculator model to obtain the score of each group.
Day one
Secondary Outcomes (2)
GALAD
Day one
circulating tumor DNA methylation
Day one
Study Arms (5)
Hepatocellular Carcinoma patients
Blood samples are collected before liver resection.
Liver cirrhosis
The diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging.
Hepatitis
Patients with various hapatitis.
Benign tumor-like lesions
Benign hepatic tumors were diagnosed based on imaging findings and histological examinations after hepatic resection.
Healthy control
The healthy control group consist of people undergoing routine medical examination. Blood samples are collected.
Interventions
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
Eligibility Criteria
Patients must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified
You may qualify if:
- Age above 18
- Establishing Diagnosis according to the European Association for the Study of Liver(EASL) criteria
- High risk group of developing HCC including liver cirrhosis and hepatitis under the confirmed diagnosis
- Able to provide sufficient and qualified blood samples for study tests
- No prior or undergoing cancer treatment (local or systematic)
- Able to provide a written informed consent
You may not qualify if:
- Obstructive jaundice patients
- Medical history of taking warfarin
- With other known malignant tumors or multiple primary tumors
- Patients with autoimmune diseases, genetic diseases, mental diseases/ disabilities and other diseases considered unsuitable for the study by the investigator
- During pregnancy or lactation
- Recipient of blood transfusion within 3 months prior to study blood draw
- Insufficient qualified blood sample for study test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Singlera Genomics Inc.lead
- The First Hospital of Jilin Universitycollaborator
Study Sites (3)
The First Hospital of Jilin University
Jilin, China
Eastern Hepatobiliary Surgery Hospital
Shanghai, China
Tianjin Third Central Hospital
Tianjin, China
Related Publications (3)
Yang T, Xing H, Wang G, Wang N, Liu M, Yan C, Li H, Wei L, Li S, Fan Z, Shi M, Chen W, Cai S, Pawlik TM, Soh A, Beshiri A, Lau WY, Wu M, Zheng Y, Shen F. A Novel Online Calculator Based on Serum Biomarkers to Detect Hepatocellular Carcinoma among Patients with Hepatitis B. Clin Chem. 2019 Dec;65(12):1543-1553. doi: 10.1373/clinchem.2019.308965. Epub 2019 Oct 31.
PMID: 31672853BACKGROUNDLiu S, Sun L, Yao L, Zhu H, Diao Y, Wang M, Xing H, Lau WY, Guan M, Pawlik TM, Shen F, Xu M, Tong X, Yang T. Diagnostic Performance of AFP, AFP-L3, or PIVKA-II for Hepatitis C Virus-Associated Hepatocellular Carcinoma: A Multicenter Analysis. J Clin Med. 2022 Aug 29;11(17):5075. doi: 10.3390/jcm11175075.
PMID: 36079006BACKGROUNDYang T, Wang N, Wang F, Liu H, Shen F, Lv G. Refinement and validation of a comprehensive clinical diagnostic model (GAMAD) based on gender, age, multitarget circulating tumour DNA methylation signature and commonly used serological biomarkers for early detection of hepatocellular carcinoma: a multicentre, prospective observational study protocol. BMJ Open. 2023 Sep 18;13(9):e076467. doi: 10.1136/bmjopen-2023-076467.
PMID: 37723113DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tian Yang, Ph.D
Eastern Hepatobiliary Surgery Hospital
- STUDY CHAIR
Guoyue Lv, Ph.D
The First Hospital of Jilin University
- PRINCIPAL INVESTIGATOR
Fengmei Wang
Tianjin Third Central Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2022
First Posted
November 25, 2022
Study Start
October 19, 2022
Primary Completion
October 1, 2024
Study Completion
December 1, 2024
Last Updated
April 1, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).