Hepatocellular CarcinomaNCT05626985
Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Singlera Genomics Inc. at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- GAMAD
- How many people
- 2,000 participants
- Where
- 3 sitesChina
- Study dates
- 19 Oct 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
The First Hospital of Jilin University
Jilin City
Nanya Wang, Ph.D
- Recruiting
Eastern Hepatobiliary Surgery Hospital
Shanghai
Tian Yang, PHD
- Recruiting
Tianjin Third Central Hospital
Tianjin
Fengmei Wang, PHD
About this study
Official title: Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- GAMAD
- Keywords
- early detection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAMADDiagnostic test
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular Carcinoma patients | Blood samples are collected before liver resection. Receives: Diagnostic Test: GAMAD | |
| Liver cirrhosis | The diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging. Receives: Diagnostic Test: GAMAD | |
| Hepatitis | Patients with various hapatitis. Receives: Diagnostic Test: GAMAD | |
| Benign tumor-like lesions | Benign hepatic tumors were diagnosed based on imaging findings and histological examinations after hepatic resection. Receives: Diagnostic Test: GAMAD | |
| Healthy control | The healthy control group consist of people undergoing routine medical examination. Blood samples are collected. Receives: Diagnostic Test: GAMAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAMAD
Using GAMAD calculator model to obtain the score of each group.
Measured: Day one
Secondary outcomes (2)
GALAD
Using GALAD calculator to obtain the score of each group.
Measured: Day one
circulating tumor DNA methylation
Using circulating tumor DNA methylation to obtain diagnostic value in pre-specified subgroups.
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start19 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singlera Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Hospital of Jilin University
- Responsible party
- Sponsor
- Investigators
- Tian Yang, Ph.D, Principal investigator, Eastern Hepatobiliary Surgery HospitalGuoyue Lv, Ph.D, Study chair, The First Hospital of Jilin UniversityFengmei Wang, Principal investigator, Tianjin Third Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626985
- Sponsor's protocol ID
- GAMAD
- Status last verified
- Mar 2024
- First submitted
- 15 Nov 2022
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 31672853Liu 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.
PubMed 36079006Yang 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.
PubMed 37723113
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol
- ClinicalTrials.gov ID
- NCT05626985
- Acronym / sponsor ID
- GAMAD
- Conditions
- Hepatocellular Carcinoma
- Keywords
- early detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Singlera Genomics Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Hospital of Jilin University
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular Carcinoma patients | – | Diagnostic Test: GAMADBlood samples are collected before liver resection. |
| Liver cirrhosis | – | Diagnostic Test: GAMADThe diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging. |
| Hepatitis | – | Diagnostic Test: GAMADPatients with various hapatitis. |
| Benign tumor-like lesions | – | Diagnostic Test: GAMADBenign hepatic tumors were diagnosed based on imaging findings and histological examinations after hepatic resection. |
| Healthy control | – | Diagnostic Test: GAMADThe healthy control group consist of people undergoing routine medical examination. Blood samples are collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAMADBlood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests. | Diagnostic test | Benign tumor-like lesions, Healthy control, Hepatitis, Hepatocellular Carcinoma patients, Liver cirrhosis |
Primary outcome
GAMAD
Time frame: Day one
Using GAMAD calculator model to obtain the score of each group.
2 secondary outcomes
GALAD
Time frame: Day one
circulating tumor DNA methylation
Time frame: Day one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Background: PubMed 31672853Yang 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.
- Background: PubMed 36079006Liu 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.
- Derived from this study: PubMed 37723113Yang 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.
- Individual participant dataSharing planned: No. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tian Yang, Ph.D principal investigator
Eastern Hepatobiliary Surgery Hospital
Guoyue Lv, Ph.D study chair
The First Hospital of Jilin University
Fengmei Wang principal investigator
Tianjin Third Central Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Singlera Genomics Inc. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nanya Wang, Ph.D (+8615804302611, wangny@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAMAD (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626985, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.