Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
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| ClinicalTrials.gov Identifier: NCT05626985 |
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Recruitment Status :
Recruiting
First Posted : November 25, 2022
Last Update Posted : April 1, 2024
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Sponsor:
Singlera Genomics Inc.
Collaborator:
The First Hospital of Jilin University
Information provided by (Responsible Party):
Singlera Genomics Inc.
| Tracking Information | ||||||||||
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| First Submitted Date | November 15, 2022 | |||||||||
| First Posted Date | November 25, 2022 | |||||||||
| Last Update Posted Date | April 1, 2024 | |||||||||
| Actual Study Start Date | October 19, 2022 | |||||||||
| Estimated Primary Completion Date | October 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
GAMAD [ Time Frame: Day one ] Using GAMAD calculator model to obtain the score of each group.
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma | |||||||||
| Official Title | Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol | |||||||||
| 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. | |||||||||
| 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, methylation, 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, prospective study. After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines. | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| 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 | |||||||||
| Condition | Hepatocellular Carcinoma | |||||||||
| Intervention | Diagnostic Test: GAMAD
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
2000 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | December 2024 | |||||||||
| Estimated Primary Completion Date | October 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts |
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| Listed Location Countries | China | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT05626985 | |||||||||
| Other Study ID Numbers | GAMAD | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Singlera Genomics Inc. | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Singlera Genomics Inc. | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | The First Hospital of Jilin University | |||||||||
| Investigators |
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| PRS Account | Singlera Genomics Inc. | |||||||||
| Verification Date | March 2024 | |||||||||