Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Jilin
Eastern Hepatobiliary Surgery Hospital
RECRUITING
Shanghai
Tianjin Third Central Hospital
RECRUITING
Tianjin
Contact Information
Primary
Nanya Wang, Ph.D
wangny@jlu.edu.cn
+8615804302611
Backup
Tian Yang, Ph.D
yangtian6666@hotmail.com
+8618917015805
Time Frame
Start Date: 2022-10-19
Estimated Completion Date: 2024-12
Participants
Target number of participants: 2000
Treatments
Hepatocellular Carcinoma patients
Blood samples are collected before liver resection.
Liver cirrhosis
The diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging.
Hepatitis
Patients with various hapatitis.
Benign tumor-like lesions
Benign hepatic tumors were diagnosed based on imaging findings and histological examinations after hepatic resection.
Healthy control
The healthy control group consist of people undergoing routine medical examination. Blood samples are collected.
Related Therapeutic Areas
Sponsors
Collaborators: The First Hospital of Jilin University
Leads: Singlera Genomics Inc.

This content was sourced from clinicaltrials.gov