Protein Biomarker in Hepatocellular Carcinoma
Maneno muhimu
Kikemikali
Maelezo
Up to 40% of HCC patients have normal AFP. Moreover, AFP can also be elevated in patients with cirrhosis or exacerbation of chronic hepatitis. Prospective studies evaluating the value of AFP in HCC surveillance have reported sensitivities of 39-64%, specificity of 76-91% and positive predictive values of 9 -32% 9-11.
Recently, a small handful of biomarkers were identified in the blood of 49 HCC patients by SELDI / MS proteomic analysis of their blood with specificity and sensitivity both at 90% 12, 13. These were truncated complement C3a, albumin, B2 microglobulin, and histidine-rich glycoprotein. In addition, insulin growth factor (IGF) and its binding protein have been shown to be novel biomarkers of HCC 14-17. A larger prospective study is necessary to validate these findings.
Other investigators have also used Surface-enhanced laser desorption / ionization time-of-flight mass spectrometry (SELDI) to study proteomics in HCC. Most of the studies included small numbers of patients and did not include independent test set or report on reproducibility most of the time. Thus, controversies continue on both the technology of SELDI and validation of the findings. Nevertheless, Ward et al reported that Kappa and Lumda immunoglobulin light chains were elevated by an average pf 50% in the serum of HCC patients (p < 0.001, sensitivity 94%, specificity 86%) with Hepatitis C related cirrhosis 18. Schwegler et al reported that SELDI-TOF MS profiling of serum can distinguish chronic Hepatitis C from HCV- related HCC with a sensitivity of 61% and a specificity of 76%. Sensitivity and specificity can be improved with the addition of AFP, des-gamma carboxyprothrombin, and GP73 19. Other reports also indicated potential marker of heat-shock protein 27 20 and complement C3a 21. However, all studies lack prospective and longitudinal follow-up with multiple serum samples from same patient. Our trial is designed to test the changes of proteomic overtime to identify the earliest possible biomarkers for HCC.
Tarehe
| Imethibitishwa Mwisho: | 01/31/2019 |
| Iliyowasilishwa Kwanza: | 04/22/2007 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 04/22/2007 |
| Iliyotumwa Kwanza: | 04/24/2007 |
| Sasisho la Mwisho Liliwasilishwa: | 02/11/2019 |
| Sasisho la Mwisho Lilichapishwa: | 02/14/2019 |
| Tarehe halisi ya kuanza kwa masomo: | 06/19/2006 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 08/13/2013 |
| Tarehe ya Kukamilisha Utafiti: | 08/13/2013 |
Hali au ugonjwa
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| 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. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Njia ya sampuli | Non-Probability Sample |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Number of participants with presence of serum protein markers [Day 1]
Hatua za Matokeo ya Sekondari
1. Number of participants with hepatocellular carcinoma (HCC) with presence of protein markers. [up to 5 years]
2. Number of participants with presence of serum protein markers with resectable and unrsectable HCC. [up to 5 years]
