Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT05626985 |
Recruitment Status :
Recruiting
First Posted : November 25, 2022
Last Update Posted : April 1, 2024
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Condition or disease | Intervention/treatment |
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Hepatocellular Carcinoma | Diagnostic Test: GAMAD |
Study Type : | Observational |
Estimated Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol |
Actual Study Start Date : | October 19, 2022 |
Estimated Primary Completion Date : | October 2024 |
Estimated Study Completion Date : | December 2024 |
Group/Cohort | Intervention/treatment |
---|---|
Hepatocellular Carcinoma patients
Blood samples are collected before liver resection.
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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.
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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.
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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.
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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. |
- GAMAD [ Time Frame: Day one ]Using GAMAD calculator model to obtain the score of each group.
- GALAD [ Time Frame: Day one ]Using GALAD calculator to obtain the score of each group.
- circulating tumor DNA methylation [ Time Frame: Day one ]Using circulating tumor DNA methylation to obtain diagnostic value in pre-specified subgroups.
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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 |
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
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
Contact: Nanya Wang, Ph.D | +8615804302611 | wangny@jlu.edu.cn | |
Contact: Tian Yang, Ph.D | +8618917015805 | yangtian6666@hotmail.com |
China | |
The First Hospital of Jilin University | Recruiting |
Jilin, China | |
Contact: Nanya Wang, Ph.D | |
Eastern Hepatobiliary Surgery Hospital | Recruiting |
Shanghai, China | |
Contact: Tian Yang, PHD | |
Tianjin Third Central Hospital | Recruiting |
Tianjin, China | |
Contact: Fengmei Wang, PHD |
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 |
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: | April 1, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
early detection |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |