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Establishment of a Clinical Diagnostic Model GAMAD for Early-stage HCC Based on Circulating Tumor DNA Methylation

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ClinicalTrials.gov Identifier: NCT05626985
Recruitment Status : Not yet recruiting
First Posted : November 25, 2022
Last Update Posted : November 25, 2022
Sponsor:
Collaborator:
The First Hospital of Jilin University
Information provided by (Responsible Party):
Singlera Genomics Inc.

Study Description
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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 case control 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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Diagnostic Test: GAMAD

Detailed Description:
GALAD score including age, sex, PIVKA-II(DCP), Alpha-fetoprotein (AFP) and alpha-fetoprotein L3 (AFP-L3), is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. While increasing studies showed the diagnostic accuracy of AFP-L3 was not as good as that of AFP or PIVKA-II, and AFP-L3 was not significant in the multivariable model. Thus, a model with better diagnostic accuracy and more suitable for Chinese patients is needed. Here, based on a multi-locus blood-based assay targeting circulating tumor DNA methylation, we aim to develop a novel diagnostic model--GAMAD (gender, age, mythylation, AFP and DCP) and validate its performance among HCC patients and those at high risk of developing HCC,such as liver cirrhosis, hepatitis patients. This is a multicenter, observational, case control study. After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines.
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Establishment of a Clinical Diagnostic Model GAMAD for Early-stage HCC Based on a Multilocus Blood-based Assay Targeting Circulating Tumor DNA Methylation: A Case-control Study
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Hepatocellular Carcinoma patients
Blood samples are collected before liver resection.
 Diagnostic Test: GAMAD
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
Liver cirrhosis
The diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging.
 Diagnostic Test: GAMAD
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
Hepatitis
Patients with various hapatitis.
 Diagnostic Test: GAMAD
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
Benign tumor-like lesions
Benign hepatic tumors were diagnosed based on imaging findings and histological examinations after hepatic resection.
 Diagnostic Test: GAMAD
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
Healthy control
The healthy control group consist of people undergoing routine medical examination. Blood samples are collected.
 Diagnostic Test: GAMAD
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.


Outcome Measures
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Primary Outcome Measures :
  1. GAMAD [ Time Frame: Day one ]
    Using GAMAD calculator model to obtain the score of each group.


Secondary Outcome Measures :
  1. GALAD [ Time Frame: Day one ]
    Using GALAD calculator to obtain the score of each group.

  2. circulating tumor DNA methylation [ Time Frame: Day one ]
    Using circulating tumor DNA methylation to obtain diagnostic value in pre-specified subgroups.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05626985


Contacts
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Contact: Nanya Wang, Ph.D +8615804302611 wangny@jlu.edu.cn
Contact: Tian Yang, Ph.D +8618917015805 yangtian6666@hotmail.com

Sponsors and Collaborators
Singlera Genomics Inc.
The First Hospital of Jilin University
Investigators
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Study Director: Guoyue Lv, Ph.D The First Hospital of Jilin University
Principal Investigator: Guoyue Lv, Ph.D The First Hospital of Jilin University
More Information
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Publications:

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Responsible Party: Singlera Genomics Inc.
ClinicalTrials.gov Identifier: NCT05626985    
Other Study ID Numbers: GAMAD
First Posted: November 25, 2022    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singlera Genomics Inc.:
early detection
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases