Clinical trial · Observational
Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GAMAD | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Hepatocellular Carcinoma patients
- description
- Blood samples are collected before liver resection.
- interventionNames
- Diagnostic Test: GAMAD
- label
- Liver cirrhosis
- description
- The diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging.
- interventionNames
- Diagnostic Test: GAMAD
- label
- Hepatitis
- description
- Patients with various hapatitis.
- interventionNames
- Diagnostic Test: GAMAD
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDYang 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 31672853
- BACKGROUNDLiu 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 36079006
- DERIVEDYang 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 37723113