A new diagnostic model for early detection of liver cancer
Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol
This study is testing a new blood test called GAMAD to see if it can help find liver cancer earlier in people who are at high risk, like those with liver cirrhosis or hepatitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Singlera Genomics Inc. Industry-sponsored |
| Locations | 3 sites (Jilin and 2 other locations) |
| Trial ID | NCT05626985 on ClinicalTrials.gov |
What this trial studies
This observational study aims to refine and validate a diagnostic model called GAMAD for the early detection of hepatocellular carcinoma (HCC). It will recruit participants from multiple centers, including healthy controls and patients with liver cirrhosis, hepatitis, and benign tumors. Blood samples will be collected before any treatment and analyzed to evaluate the diagnostic efficiency of the GAMAD model, which incorporates factors like age, sex, and specific serum biomarkers. The goal is to improve early detection rates among high-risk populations, particularly in Chinese patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are at high risk for developing HCC, such as those with liver cirrhosis or hepatitis.
Not a fit: Patients with obstructive jaundice, other known malignancies, or those currently undergoing cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis of hepatocellular carcinoma, improving treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in developing diagnostic models for liver cancer, but this specific approach with GAMAD is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jilin and 2 other locations
- The First Hospital of Jilin University — Jilin, China (Recruiting)
- Eastern Hepatobiliary Surgery Hospital — Shanghai, China (Recruiting)
- Tianjin Third Central Hospital — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Tian Yang, Ph.D — Eastern Hepatobiliary Surgery Hospital
- Study coordinator: Nanya Wang, Ph.D
- Email: wangny@jlu.edu.cn
- Phone: +8615804302611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.