Protein Biomarker in Hepatocellular Carcinoma

NCT00465842 | Terminated

• 2 other identifiers: JS0541NA_00037477
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normal Volunteers; Hepatitis; Liver Cirrhosis; Hepatocellular Carcinoma

Keywords

Hepatitis; Liver Cirrhosis; HCC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of participants with hepatocellular carcinoma (HCC) with presence of protein markers.

  up to 5 years

• Number of participants with presence of serum protein markers with resectable and unrsectable HCC.

  up to 5 years

Study Arms (7)

A - Normal Volunteers

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.

B - Hepatitis B or C carriers with normal liver functions

C - Hepatitis B or C carriers with abnormal liver functions

D - Liver Cirrhosis

Liver cirrhosis, proven by liver biopsy or on clinical evidences, such as varices on CT scan indicative of portal hypertension.

E - Hepatocellular Carcinoma (HCC) with Resection

HCC patients with resection.

F - Unresectable HCC

Unresectable HCC patients with treatment

G - Malignant HCC

HCC patients with active malignant disease and only palliative care are offered.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCC patients, normal volunteers and patients with hepatitis with/without cirrhosis

You may qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Singapore Cancer Society: collaborator

Study Sites (1)

Johns Hopkins Singapore International Medical Center

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Hepatitis; Liver Cirrhosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Alex Chang, MD

  Johns Hopkins Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: June 20, 2006
• Primary Completion: August 14, 2013
• Study Completion: August 14, 2013
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)