Hepatocellular Carcinoma Clinical Trial
Official title:
Protein Biomarkers for Early Detection and Prognostication in Hepatocellular Carcinoma (HCC)
Verified date | February 2019 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hepatocellular carcinoma (HCC) is the fifth commonest cancer in the world with poor
prognosis, as the annual mortality is almost equivalent to the incidence. This is mainly due
to late diagnosis and co-morbid liver dysfunction. HCC is prevalent in our region than in the
West due to prevalent Hepatitis B infection and carriers. At the time of diagnosis, only 10 -
20% of HCC patients are candidates for liver resection or transplantation. Almost 40-50% of
patients have such poor liver function and co-morbid conditions that only supportive cares
are offered. Thus the median survival time is 18-24 months for resectable disease, 6 months
for unresectabe disease and 3 months for metastatic disease.
Current screening methods for HCC in high risk patients depend on alpha-fetoprotein (AFP) and
ultrasound of the liver. Neither test is sensitive or specific enough for early detection.
Therefore, early diagnosis with novel protein biomarkers is needed urgently and may provides
hope to improve treatment outcome.
Our preliminary study in 49 HCC patients have identified several proteins such as truncated
complement C3a, albumin, B2 microglobulin, may be potentially helpful in early diagnosis. We
have started a large prospective and longitudinal study in July 2006, with nearly 100
patients accrued. This application is to extend and expand our current study. We aim to (i)
identify and validate novel protein biomarkers for early diagnosis of HCC (ii) conduct
longitudinal proteomics with most up-to-date methods to discover new biomarker for early
detection and prognostication of HCC (iii) set up gene and plasma depository and clinical
database for HCC in collaboration with Singapore Tissue Network.
Status | Terminated |
Enrollment | 211 |
Est. completion date | August 14, 2013 |
Est. primary completion date | August 14, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Group A: Normal volunteers without any history of liver disease and with normal liver functions test (LFT), including total protein/Albumin, LDH, ALT, AST, GGT, total bilirubin, direct and indirect bilirubin and do not belong to group B. Volunteers will be screened using questionnaires. Those deemed suitable will then be asked to have the blood test done. All blood tests are done free of charge to subjects. - Group B: Hepatitis B or C carriers with normal liver functions. - Group C: Hepatitis B or C carriers with abnormal liver functions. - Group D: Liver cirrhosis, proven by liver biopsy or on clinical evidences, such as varices on CT scan indicative of portal hypertension. - Group E: HCC patients with resection. - Group F: Unresectable HCC patients with treatment. - Group G: HCC patients with active malignant disease and only palliative care are offered. - Signed Informed Consent -= 18 years of age - In this trial, diagnosis of HCC is established with either (a) known hepatitis B or C carrier, and space occupying lesion(s) in the liver and AFP > 400ng/ml or (b) cytological or histological confirmation by biopsy Exclusion Criteria: There is no exclusion criteria |
Country | Name | City | State |
---|---|---|---|
Singapore | Johns Hopkins Singapore International Medical Center | Singapore |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Singapore Cancer Society |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with presence of serum protein markers | Number of participants with truncated complement C3a, albumin, B2-microglobulin and histidine-rich glycoprotein, IGF-I, and IGF-II on first blood sample. | Day 1 | |
Secondary | Number of participants with hepatocellular carcinoma (HCC) with presence of protein markers. | To study the prospective and longitudinal value of these protein markers in detecting HCC by regular measurement of these proteins and follow up with routine clinical practice in high-risk patients. | up to 5 years | |
Secondary | Number of participants with presence of serum protein markers with resectable and unrsectable HCC. | up to 5 years |
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