Viewing Study NCT01388101



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Study NCT ID: NCT01388101
Status: UNKNOWN
Last Update Posted: 2012-12-21
First Post: 2011-07-01

Brief Title: Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor e- Ab Sensor
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor e- Ab Sensor
Status: UNKNOWN
Status Verified Date: 2012-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To develop a real-time diagnostic technique with e- Ab sensor for specific LECT2 detection in clinical specimens of Hepatocellular carcinoma HCC patients the investigators conduct a prospective clinical study In comparison with results from direct sequencing of LECT2 the investigators evaluate the performance of e- Ab sensor including reproducibility sensitivity specificity and cross-reaction With such technique the investigators can obtain LECT2 information of HCC patients in cost-saving and time-saving way and can offer more individualized treatment for our patients
Detailed Description: Hepatocellular carcinoma HCC is one of the most common types of cancer in the world High cancer recurrence is still the major cause of death of HCC patients The major poor prognostic factors included vascular invasion high α-FP large tumor size or tumor satellitosis etc Among the various literature reports with multivariate analysis vascular invasion of the tumor is the major contribution of high recurrence and poor survival Therefore identifying differentially expressed genes between vascular-invasion and non-vascular invasion of HCCs is important

After suppression subtractive hybridization and microarray experiments the investigators identified 20 differentially-expressed genes between vascular-invasive and non-vascular invasive HCCs One of the most interesting gene is leukocyte cell-derived chemotaxin 2 LECT2 Further evaluation of the role of LECT2 on HCCs the investigators found 1 Higher invasiveness the lower of LECT2 gene expression in the HCC cell lines 2 Conditioned medium with high LECT2 content will inhibit HCC invasion 3 The invasion ability decreased in LECT2-overexpression hepatoma cell line 4 In transendothelial cell migration assay the investigators could observed invasion ability increased when LECT2 was knockdown in HCC cell line 5 The lower expression of LECT2 gene in human HCCs correlate with higher tumor stage early recurrence and poor prognosis 6 In vivo experiments revealed LECT2 can inhibit the ability of intravasation or metastatic ability of HCC

Electrosensing antibody probing system e- Ab sensor which was developed for the rapid and sensitive detection of hapten proteins or viral antigen in medical samples will be used for analyzing the interaction kinetics between specific anti- LECT2 and its antigen LECT2 with liver cancer present in the specimens of patients with liver cancer The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip eAbchip or lateral flow through eAbsignal formats In electrosensing antibody probing semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds targeted molecules ie specific LECT2 in the test specimens From assessment of the electric signature of semiconductive mutation-specific anti-LECT2 antibodies the eABprobe could offer sensitive detection and precise quantification of specific LECT2

To develop a real-time diagnostic technique with e- Ab sensor for specific LECT2 detection in clinical specimens of HCC patients the investigators conduct a prospective clinical study The investigators evaluate the performance of e- Ab sensor including reproducibility sensitivity specificity and cross-reaction With such technique the investigators can obtain LECT2 information of HCC patients in cost-saving and time-saving way and can offer more individualized treatment for our patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None