Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05342350
Other study ID # IRB00250209
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 15, 2022
Est. completion date July 1, 2032

Study information

Verified date January 2024
Source Johns Hopkins University
Contact Doan Y Dao, MD
Phone 410-955-9696
Email ddoa1@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study has two purposes. One is to conduct a phase IV biomarker validation study in which the investigators will prospectively survey a cohort of patients at risk for liver cancer using semi-annual abdominal ultrasound and GALAD Score for 5 years. The GALAD score is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. One is to establish a bio-repository of longitudinally collected bio-specimens from patients with fibrosis/cirrhosis as a reference set for future research.


Description:

Vietnam and Saudi Arabia have some of the highest disease burdens of liver cancer globally. Early detection in asymptomatic patients who are at risk for liver is a strategy to improve survival outcomes in liver cancer management. GALAD score (gender, age, alpha-feto protein (AFP)-L%, AFP and DCP) is a serum biomarker-based panel that can improve HCC early detection in patients with liver fibrosis and cirrhosis. In case-control studies and studies with the design of prospective specimen collection, and retrospective blinded evaluation, GALAD has demonstrated promising clinical utility. However, in order to ascertain its potential role in the surveillance of liver cancer early detection, GALAD needs to be validated prospectively for clinical surveillance of liver cancer (i.e. phase IV biomarker validation study). Thus, the investigators propose to conduct a phase IV biomarker validation study to prospectively survey a cohort of patients at risk for HCC (i.e. patients with compensated cirrhosis and irrespective of cirrhosis etiologies), using semi-annual abdominal ultrasound and GALAD Score for 5 years. In doing so, the investigators aim to validate the potential role of GALAD Score for clinical surveillance and early detection of HCC in Vietnam and Saudi Arabia. Additionally, the investigators will collect and archive biospecimens to develop a bio-repository for liver disease. The biorepository will encourage the sharing of biospecimens and collaboration among physicians or physician-researchers between the US, Vietnam, and Saudi Arabia.


Recruitment information / eligibility

Status Recruiting
Enrollment 1600
Est. completion date July 1, 2032
Est. primary completion date July 1, 2027
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study and up to 5 years post-study follow up 3. Adults aged 18 or older 4. Both genders and all ethnicities 5. Willingness to give written, informed consent to be enrolled into the database 6. Collection of biosamples (serum, plasma, and urine) at each of the 6 months follow up during the study duration 7. Individuals already confirmed to have cirrhosis with MELD = 15 from any etiology (chronic HBV, chronic HCV, NASH cirrhosis, etc.) 8. For chronic HBV and/or /HCV carrier, with or without on treatment 9. Reside in Vietnam or Saudi Arabia at the time of study and provides contact information (email and/or cell phone number for texting) 10. No prior or current treatment of HCC 11. No cancer history within 5 years 12. No participation in a trial for HCC Treatment 13. No prior solid organ transplant 14. Albumin, Bilirubin, Creatinine and INR labs within past 30 days 15. Imaging showing no HCC within 180 days 16. Diagnosis of fibrosis and cirrhosis based on: histology, image showing cirrhotic liver with splenomegaly and platelets <120 mm3, or esophageal or gastric varices on endoscopy AND presence of chronic liver disease/Fibroscan/Fib-4/APRI/ARFI. For viral hepatitis, kPa>=9kPa, APRI >=1; for NAFLD/NASH (FIB-4 > 1.3 & TE > 8kPa) 17. No significant hepatic decompensation 18. No hepatorenal syndrome 19. AFP labs within 180 days irrespective of AFP titer 20. Two phone numbers and personal identification numbers (CMND number) 21. No known AIDS related diseases 22. No significant co-morbid conditions with life expectancy <5 years 23. No other cancer(s) Exclusion Criteria: 1. Decompensated cirrhosis (variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, and/or hepatorenal syndrome) or MELD>15 2. Individuals who already have HCC, with or without HCC treatment 3. On liver transplantation list or anticipated to be on the liver transplantation list during the study duration 4. Individuals who cannot, do not want to, or refused to sign the informed consent form (ICF) 5. Any serious or active medical or psychiatric illness, which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol 6. Documentation was not adequate 7. Taking Vitamin K within 7 days prior to clinic follow or having disease affecting Vitamin K levels. 8. Known HIV positive 9. Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements

Study Design


Intervention

Other:
GALAD Score
GALAD score, a blood-based biomarker panel (gender, age, AFP, AFP-L3%, DCP)

Locations

Country Name City State
Saudi Arabia King Faisal Specialist Hospital and Research Center in Jeddah Jeddah
Saudi Arabia National Guard Hospital in Jeddah Jeddah
Saudi Arabia King Faisal Specialist Hospital and Research Centre in Riyadh Riyadh
Saudi Arabia King Saud University Medical Center Riyadh
Saudi Arabia National Guard Hospital in Riyadh Riyadh
Vietnam Medic Ca Mau Ca Mau
Vietnam Dong Da Hospital Ha Noi
Vietnam Institute of Gastroenterology and Hepatology Ha Noi
Vietnam Medic Medical Center-Ho Chi Minh City Ho Chi Minh City
Vietnam Binh An Hospital Rach Gia Kien Giang

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University King Faisal Specialist Hospital and Research Center in Riyadh (Saudi Arabia), Medic Medical Center (Viet Nam)

Countries where clinical trial is conducted

Saudi Arabia,  Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary GALAD performance for liver cancer early detection Performance of GALAD score determined in association with liver cancer detection by LiRADS criteria in a cohort with compensated cirrhosis undergoing prospective surveillance every 6 months for 5 years. 5 years
Secondary Establishment of a bio-repository of longitudinally collected from patients with cirrhosis to be used for future studies Proportion of study participants agrees to consent for bio-specimen when invited 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Completed NCT03268499 - TACE Emulsion Versus Suspension Phase 2
Recruiting NCT05263830 - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT05095519 - Hepatocellular Carcinoma Imaging Using PSMA PET/CT Phase 2
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Completed NCT05068193 - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers Phase 1
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Active, not recruiting NCT04039607 - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma Phase 3
Terminated NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2