Liver Rapid Reference Set Application: Gianluigi Giannelli - Univ of Bari (2008)

Abbreviated Name
Liver Rapid Ref Set App: Giannelli (2008)
Lead Investigator
Giannelli, GianluigiUniversity of Bari
Coordinating Investigator
Feng, Ziding Fred Hutchinson Cancer Center
Involved Investigators


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To evaluate biomarker performanceof SCCA, SCCA-IC, AFP-IC and PIVKA-II versus AFP in an out-side cohort of LC and HCC patients. Our hypothesis is that the performance of the investigated biomarkers is affected by the accuracy of patient criteria inclusion, and potential inaccuracy of serum storage. Therefore, the study we have already reported in the literature is not yet clear cut and conclusive, nevertheless, the data seem promising to be further investigated. Our goals is to clinically validate proposed biomarkers in an external sample population, with more stringent criteria of selection and of data analysis. The performance of each marker will be evaluate through a ROC (Receiving Operating Charachteristic) analysis determining the area under the ROC curve, sensitivity and specificity. A multivariate logistic model will be also carried out to evaluate the performance of combination of marker.

Analytic Method

So far the general attitude to investigating a biomarker has been to search for an ideal molecule with a high specificity and sensitivity. However, the reality has been very different and all the investigators have taken this as a negative result of the potential biomarker investigated. Nevertheless, there is growing evidence that HCC is a very heterogeneous type of cancer, in terms of epidemiology, etiology and clinical outcome. Therefore, we hypothesise that several biomarkers need to be investigated in order to properly address these differences. This hypothesis is based on a number of findings: 1) in different studies there was a high variability in terms of sensitivity and specificity of the biomarkers investigated, even in the case of AFP. 2) Other biomarkers such as DCP have been proposed by oriental authors, but poorly accepted in the west. 3) Some biomarkers may predict a particular clinical outcome of HCC, as in the case of DCP associated with vascular invasion. 4) Recently, we have reported that SCCA significantly improves the diagnostic accuracy of AFP, but only in viral-related disease. Some new data recently submitted show that in alcohol-related non virus related disease, SCCA does not play any role, while DCP has a better performance. 5) Recently, it has been suggested that tissue expression of SCCA represents an early event in the onset of HCC, being more expressed in dysplastic compared to regenerative nodules. 6) Consistently with these data, our preliminary data recently submitted, show that SCCA is more strongly expressed in smaller than in larger HCC nodules.


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  • No publications available at this time for this protocol.


Data Collections

  • No data collections available at this time for this protocol.
Start Date
Oct 13 2008
Estimated Finish Date
Dec 13 2008
Finish Date
Oct 12 2009
Protocol ID
Protocol Type
Reference Set
Field of Research
Collaborative Group
G.I. and Other Associated Cancers Research Group
Cancer Types
  • Liver cell carcinoma

Associated Forms